>> AND IF YOU COULD ALSO
MAKE SURE YOU LET US KNOW IF
YOU HAVE FEEDBACK IN THE
QUESTION, LET US KNOW THAT
SO THAT WOULD BE HELPFUL.
THANKS VERY MUCH.
GO AHEAD, KELLY.
>> NO PROBLEM, I AM KELLY
KING FROM THE NATIONAL
INSTITUTE OF DEAFNESS AND
OTHER.
>> >>>: AND NICHD HAS BEEN
SUPPORTING THE CLINICAL
TRIAL YOU WILL BE HEARING
FROM TODAY ON Dr. HARTNICK
SO IT IS A PLEASURE TO
INTRODUCE TODAY'S SPEAKER.
WITH MORE THAN 15 YEARS
EXPERIENCE IN PEDIATRIC
OTOLARYNGOLOGY AND PEDIATRIC
AIRWAY VOICE SPECIAL
SWELLING CENTER.
Dr. HARTNICK HAS BEEN
SPEAKER AT REGIONAL,
NATIONAL AND INTERNATIONAL
MEETINGS AND PUBLISHED OVER
10 PAPERS IN THE FIELD.
HE SERVED AS DIRECTOR ON THE
BOARD OF DIRECTORS AND
VICE-CHAIR ON THE OUTCOMES
OF THE DEPARTMENT OF
OTOLARYGOLOGY.
HE IS FEATURED IN THE
JOURNAL OF VOICE AND OTHER
AD HOC ORGANIZATIONS.
HIS CLINICAL INTERESTS
INCLUDE PEDIATRIC AIRWAY AND
HIS PRIMARY INTERESTS
INCLUDE THE MATURATION OF
PEDIATRIC VOCAL FOLDS AND
SURGERY.
HE IS ALSO THE CHAIR IN
OTOLARYGOLOGY VOICE SURGERY.
SO PLEASED TO HAVE YOU WITH
US TODAY AND I WILL TURN IT
OVER TO YOU.
>> THANKS, KELLY AND I WILL
TELL YOU OUR FIRST GOAL, I
MYSELF MESS UP OTOLARYGOLOG
Y OVER TIME SO YOU GOT IT
AND PRODUCTION CAN SOMETIMES
BE THE HARDEST PART.
I AM REALLY GLAD TO BE WITH
EVERYBODY TODAY AS WE TALK
ABOUT OUR WORK TOGETHER
BECAUSE THIS IS NOT REALLY
MY WORK BUT OUR WORK.
THIS IS A TEAM SPORT.
AND ALONG WITH MY FELLOW
INVESTIGATORS, Dr. RYAN
SATGOW WHO RUNS THE PROGRAM
AT MASS GENERAL AND THE
SLEEP TEAM, JUST AN
ENORMOUS -- THIS IS A
NATIONAL ENDEAVOR AND
SUPPORTED BY THE NIH AND WHO
HAVE HELPED EVERY STEP ALONG
THE WAY.
SO WITH THAT SAID, I WILL
TALK TO YOU ABOUT OUR
EXPERIENCE WITH
PEDIATRIC-FOE GLOSS SALARY
STIMULATION AND WHERE WE ARE
AND I THOUGHT I WOULD TALK
ABOUT THE STUDY ITSELF, TO
REALLY SET THE STAGE OF WHY
WE'RE TALKING ABOUT THIS
AND --
>> Dr. HARTNICK?
SORRY TO INTERRUPT YOU BUT
YOU ARE NOT SHARING YOUR
SCREEN AND NEED TO SHARE
YOUR SLIDES.
>> YEAH, THAT WOULD BE
HELPFUL, HOLD ON.
>> AM I NOW?
>> YES.
>> CAN YOU SEE THE FULL
SCREEN?
>> YES WE CAN.
>> SO THIS IS NOT SOMETHING
NEW TO ANYBODY ON THIS ZOOM
CALL IN THE SENSE THAT
CHILDREN WITH DOWN SYNDROME
HAVE ISSUES WITH SLEEP
APNEA.
AND THEY WALK DOWN A VERY
SIMILAR ROAD THAT CHILDREN
WITHOUT DOWN SYNDROME HAVE
WHO HAVE SLEEP APNEA, THAT
WE OFTEN START THINKING
ABOUT COULD IT BE THEIR
TONSILS AND ADENOIDS ARE
DIVERGED AND SHOULD WE
REMOVE THEM.
AND MAY BE CHILDREN WHO HAVE
THEIR TONSILS AND ADENOIDS
REMOVED HAVE THEIR SLEEP
APNEA TREATED.
CHILDREN WITHOUT THE DOWN
SYNDROME PRIMARILY HAVE A
LONG TONGUE OR TONGUE BASE
AND THERE ARE OTHER ISSUES
BUT PRIMELY WITH THE TONGUE,
THE PERSISTENCE OF SLEEP
APNEA DESPITE THE TONSIL AND
ADENECTOMY IS A DIFFICULTY.
AND THIS IS KNOWN THROUGH A
LONG TIME CARING FOR KIDS
WITH DOWN SYNDROME AND
REALLY THINKING AS A TEAM
THROUGH THE PRO GENESIS OF
WORK AND THEN THE STUDY
ITSELF.
WHAT I WOULD SAY IS THAT AS
WAS THE CASE WITH THE FIRST
CHILDHOOD PRIOR TO THIS
PARTICULAR DEVICE AND
IMPLANTATION, WE WERE DOING
SURGERIES WITH TONGUE BASE
REDUCTION WHICH WE'RE STILL
DOING AND EVEN TRACHEOTOMY
AND THE GOAL OF THAT WAS TO
REMOVE THE TRACHEOTOMY.
I MENTION CPA P AS POSITIVE
PRESSURE AND CLEARLY IT CAN
BE TOLERATED.
IT IS AN ABSOLUTE TREATMENT
AND CAN BE VERY HELPFUL.
IT TREATS THE PROBLEM AS
LONG AS YOU WEAR THE MASK
AND THAT IS WHERE MANY
PEOPLE HAVE ISSUES WITH THE
TERMS OF COMPLIANCE.
WHEN I PUT THIS SLIDE HERE
TO SHOW THAT THERE ARE MANY
CHILDREN EACH YEAR WHO ARE
BORN WITH DOWN SYNDROME AND
AS YOU WALK DOWN THE LINE
FROM THE NUMBER OF KIDS WHO
HAVE DOWN SYNDROME TO THE
NUMBER OF KIDS WHO HAVE
PERSISTENT SLEEP APNEA AND
NUMBER OF CHILDREN WITH
PERSISTENT SLEEP APNEA
DESPITE THE
ADENOTONSILLECTOMIES WITH
CPA P, IT IS A LARGE NUMBER
AND WHEN YOU THINK OF PEOPLE
FROM STATES, COUNTRIES
ACROSS THE WORLD, THESE
NUMBERS VARY DEPENDING ON
WHERE YOU LIVE BUT IT IS NOT
INCONSEQUENTIAL.
MY PARTICULAR ROAD WITH THIS
BEGAN IN 2014 WITH A
PUBLICATION IN THE NEW
ENGLAND JOURNAL, HYPOGLOSSAL
STIMULATION IN ADULTS.
THIS WAS TECHNOLOGY THAT WAS
INITIALLY FUNDED IN PART BY
THE DEPARTMENT OF DEFENSE
BECAUSE IT WAS DIFFICULT FOR
SOLDIERS TO DEPLOY IF THEY
WERE WEARING CPAP VESTS AT
NIGHT SO THIS PARTICULAR
HYPOGLOSSAL IMPLANTATION WAS
PERCEIVED IN THAT LIGHT AND
CENTERED AROUND ADULT
FOCUSED TRIAL.
AND IT INSTRUCTION ME FROM A
PEDIATRIC SITUATION
ESPECIALLY KIDS WITH DOWN
SYNDROME IS IT VARIOUS WITH
CHILDREN WHO HAVE DOWN
SYNDROME AND THE DOWN
SYNDROME MAY CHANGE OVER THE
COURSE OF THEIR LIFE BASED
ON THEIR PHENOTYPE WHEREAS
CHILDREN WITH LARGE TONGUE
BASES SUFFER THROUGHOUT
THEIR LIFE SO THIS IS A
LARGE SITUATION AND THIS IS
LARGELY PICTORAL BUT THE
PREMISE IS THEY HAVE A
SENSOR -- THINK ABOUT A
PACEMAKER, WHICH THIS IS A
FORM OF A PACEMAKER PACING
THE TONGUE THAT SENSES WHEN
THE CHILD IS TRYING TO TAKE
A BREATH AND AT NIGHT DURING
THE TIME ESPECIALLY OF REM
SLEEP WHEN THE MUSCLES RELAX
AND THE TONGUE BASE CAN FALL
BACK AND BE A INSTRUCT.
SO THE CHILD WILL BE TRYING
TO TAKE A BREATH BUT CAN'T
BECAUSE OF THE OBSTRUCTION.
THIS CAN BE A SIGNAL THAT
SENDS IT TO THE PROCESSOR
UNDER THE SKIN WHICH SENDS A
SIGNAL TO THE WIRE THAT GOES
TO THE BRANCHES OF THE NERVE
THAT MOVE THE TONGUE CALLED
YOUR HYPOGLOSSAL NERVE WITH
A CAN YOU HAVE HERE THAT
PUSHES THE TONGUE FORWARD.
HYPOGLOSSAL HAS NERVES WHICH
CAN MOVE YOUR TONGUE
FORWARD, BACKWARD AND
SIDEWAYS SO IT WILL PUT THE
CAN YOU HAVE UNDER THE
TONGUE TO MAKE IT GO FORWARD
AND NOT, INCLUDING THOSE
THAT GO SIDE TO SIDE OR
BACKWARDS.
TO PUT A HUMAN FACE ON THIS
STUDY AND ITS IMPORTANCE,
THIS IS AN 11-YEAR-OLD
DAUGHTER WITH DOWN SYNDROME
WHO HAD SEVERE REFRACTORY
SLEEP APNEA AND THE HYPOXIA
IN CHILDREN GREATER THAN 10
IS SEVERE SLEEP APNEA AND
COULD NOT TOLL LATE THE CPA
P AND HER DAD DESCRIBES SHE
WAS ALWAYS SO TIRED, GETTING
FRUSTRATED WHEN SPEAKING,
COULDN'T FIND THE RIGHT WORD
TO SAY TO MAKE HERSELF
UNDERSTOOD, LIKE SHE KEPT
FOR GETTING THE WORD.
WHEN A CHILD LIKE HER
SHOWS -- BEFORE WE PUT THE
IMPLANT IN, WE WANT TO BE
REALLY SURE THAT THE ANATOMY
IS IN FACT -- THAT WE DON'T
ASSUME KIDS WITH DOWN
SYNDROME HAVE TONGUE
OBSTRUCTION AND THAT IS
THEIR PRIMARY SOURCE.
SO THIS IS CALLED A SLEEP
ENDOSCOPY THAT IS DONE WITH
ANY FORM OF MEDICINE
MIMICKING SLEEP, THIS IS A
SCOPE GOING DOWN THE NOSE
AND HERE YOU ARE SEEING THE
TONGUE AND AS WE LIFT THE
TONGUE FORWARD, IN THE THE
EPIGLOTTIS AND THE AIRWAY
AND AS WE LIFT IT FORWARD,
IT OPENS.
THIS WE LET IT GO BACK, IT
CLOSES AGAIN.
SO THIS MAKES SURE THERE IS
NOTHING ON THE TONSILS AND
THE PALATE IS NOT
OBSTRUCTING.
THIS SLEEP ENDOSCOPY IS JUST
CRUCIAL FOR US TO BE ABLE TO
DIAGNOSIS THE CONDITION AND
THEY NEED TO BE OBSTRUCTING
LIKE THEY WOULD WHEN THEY
ARE GENERALLY SLEEPING SO
YOU HAVE TO WORK TOGETHER
WITH THE TEAM.
SINCE ONE OF THE CONTRA
INDICATIONS TO HYPOGLOSSAL
IMPLANTATION, THE PAL LIT
THAT IS CLOSING THE NOSE AND
THE MOUTH, IF IT IS
OBSTRUCTING, THAT IS NOT
INNER SAID THE BY THE 12TH
CRANIAL NERVE OF THE
HYPOGLOSSAL NERVE SO IF WE
SEE THAT, WE WOULD CHANGE
THAT PALATE BEFORE WE START
THINKING ABOUT A HYPOGLOSSAL
IMPLANT.
BUT FOR CHILDREN WITH
TKHRO*EPLD, THE TUBE THAT
CONTROLS THE FLUID FROM THE
BACK OF THEIR NOSE AND EARS
CALLED THE EUSTACHIAN TUBE,
THAT IS ALSO LARGE SO IT IS
IMPORTANT TO MAKE SURE THE
KIDS WHO ARE CANDIDATES FOR
THE PROCEDURE TO BE SURE YOU
KNOW THEY HAVE ANATOMICAL
DIFFERENCES THAN THOSE WHO
DON'T AND TO MAKE SURE WE
LOOK FOR THIS.
AGAIN, THE SURGERY ITSELF
AND THIS FORM OF TECHNIQUE,
ALL OF THESE THINGS ARE
UNDERNEATH AND ALL OF THE
PROCESSES VARY.
THERE ARE OTHER DIFFERENCES
SPECIFIC TO PEDIATRIC
IMPLANTATION AS OPPOSED TO
ADULT IMPLANTATION.
ONE ISSUE IS THAT IN ADULTS
WITHOUT DOWN SYNDROME AND
CHILDREN WITHOUT DOWN
SYNDROME, WE CAN
HYPER-EXTEND THE NECK TO
REALLY BE ABLE TO FEEL UNDER
THE JAW AND BE ABLE TO PLACE
THE CUFF MORE READILY TO
FIND THE NERVE WHERE FOLKS
WITH DOWN SYNDROME CAN HAVE
LAXITY WITH THE C1 AND C2
LIGAMENTS AND CANNOT EXTEND
THEIR NECKS.
SO IT IS A SMALLER SPACE AND
WE HAVE DEVELOPED TECHNIQUES
WITH KIDS FOR DOWN SYNDROME
THAN IS GENERALLY
RECOMMENDED BY ADULTS BUT
THEY ARE SAFE AND NOW
TESTED.
THE OTHER THING WE HAVE TO
BE CAREFUL ABOUT IS WITH
CHILDREN, THEIR CHEST CAGES
ARE A LITTLE DIFFERENT THAN
ADULTS.
WITH CHILDREN WITH DOWN
SYNDROME, THEIR RIBS MOVE UP
A LITTLE MORE VERTICALLY AND
THEIR MUSCLES ARE A LITTLE
THINNER SO THE WAY THE
IMPLANT GOES IN IN ADULTS IS
BETWEEN MUSCULAR LEVELS.
WHEREAS IN CHILDREN, SINCE
MUSCLE LAYERS ARE NOT SO
DEVELOPED AND WE DON'T WANT
TO INJURE THE LUNGS, WE PUT
THE SENSOR RIGHT ABOVE THE
RIB IT IS USING IT AS AN
ANATOMIC LANDMARK AND AS IT
EXPANDS OUT THROUGHOUT THE
PEDIATRIC POPULATION, IT IS
JUST VERY IMPORTANT TO
REALIZE THAT KIDS ARE NOT
LITTLE ADULTS, THAT
EVERYTHING CHANGES WITH TIME
AND YOU HAVE TO BE SURE YOU
KNOW WHAT YOU ARE DOING AND
WHAT THE DIFFERENCES ARE.
ANOTHER PART OF THE PROCESS
IS TO REALIZE THAT
HYPOGLOSSAL IMPLANTATION IS
NOT JUST WHAT HAPPENS WHEN
YOU GET ON THE TABLE AND
FINISHING WHEN YOU GET OFF
THE TABLE, THAT IT IS REALLY
IMPORTANT THAT PARENTS
PREPARE THEMSELVES FOR WHAT
THIS WILL LOOK LIKE BEFORE
AND AFTER AND WE'RE GOING TO
HAVE A WONDERFUL PARENT WHO
WILL DESCRIBE THAT
EXPERIENCE AND I AM VERY,
VERY GRATEFUL FOR THAT.
BUT TO SAY THAT AFTERWARDS,
IT IS A YEAR THAT WE GET TO
KNOW EACH OTHER VERY WELL.
THERE ARE SLEEP STUDIES AT 1
MONTH, 3 MONTHS, 6 MONTHS
AND 12 MONTHS BECAUSE WE ARE
TRYING TO INCREASE THE
VAULTAGE OR MONITOR OF THE
DEVICE TO TAKE AWAY SLEEP
APNEA BUT NOT TO AROUSE THE
CHILD.
THE CHILDREN HAVE TO GET
USED TO THIS SO WE REALLY
NEED TO DO THAT.
THERE ARE ALSO DEVICES, JUST
LIKE A PACEMAKER OR COCHLEAR
IMPLANT OR OTHER DEVICE, IT
IS A ELECTRICAL CIRCUIT THAT
AFFECTS THE MUSCLES SO IT
HAS TO DESCEND SO WE HAVE TO
READ IT.
IF THE PARENTS ARE SAYING
WHY ARE WE DOING ALL THESE
SLEEP STUDIES, THERE ARE
SOMETIMES WE LOOK AT THIS
IMPLANT, IT WASN'T WORKING
SO WELL.
THERE WAS A CHILD IN THE
30s AND COULDN'T GET BELOW
THE 20s WHICH IS SEVERE
SLEEP APNEA AND NEEDED TO
KNOW WHY.
AND SO WE TEND TO LOOK IN
THE SLEEP LAB ARE THE
CHILDREN TRYING TO DRAW A
BREATH BUT IT IS NOT QUITE
WORKING AND WE CALL THAT
HYPOXIA OR IS THE TONGUE NOT
MOVING AT ALL, WE CALL THAT
APNEIC.
SO THERE ARE THINGS IF A
CHILD IS TRYING TO MOVE THE
TONGUE IN THE SLEEP LAB TO
MOVE THE TONGUE.
AND WE BRING THE CHILDREN
BACK TO SAY WHAT
CONFIGURATION AND AESTHETICS
DO WE DO TO GET THAT TONGUE
TO MOVE FORWARD SO VERY
CLOSE FOLLOW UP WITH THE
PARENTS TELLING YOU HOW
THEIR CHILDREN ARE DOING IS
SUPER IMPORTANT.
IN THIS PARTICULAR CHILD,
THE WAY SHE WAS SLEEPING
EVERY TIME SHE TURNS TO THE
POSITION SHE WAS MORE
COMFORTABLE WITH, SHE
HAPPENED TO INVERT THE
SIGNAL SO THE MACHINE WAS
READING IT WHEN SHE WAS
TRYING TO TAKE A BREATH IN
AS IF SHE WAS TAKING THE
BREATH OUT AND VICE VERSA.
WITH ADVANCED SETTINGS, YOU
CAN FLIP THAT AND NOW IT HAS
GONE DOWN FROM 30 TO 1.5 SO
COMPLETELY TREATED AND WHEN
YOU END WITH THE DAD'S
REPORT THAT SHE WAS SO TIRED
AND KEPT FORGETTING THE
WORDS, NOW SHE HAS NOT
FORGOTTEN THE WORD ANYMORE.
SO FORGET ABOUT THE SCORE,
IT IS HOW THE CHILDREN ARE
DOING AFTERWARDS AND HOW
THEY ARE LIVING THEIR LIVES
AND THIS IS THE REASON YEAR
DOING -- REASON WE ARE
DOING THE STUDY TO SEE HOW
TRUE THIS IS.
SO FROM 2015-2019 WE DID A
MULTIINSTITUTIONAL STUDY, A
FDA-APPROVED IDE
MULTIINSTITUTIONAL STUDY
WHERE THEY HAD THE BMI UNDER
50 PERCENT, HAD THEIR
TONSILS REMOVED, TRIED AND
JUST COULD NOT WEAR A CPA P.
YOU KNOW, WE WERE LEARNING
ABOUT THE TITRATION EFFECTS
OF THIS AND HOW DID WE TEACH
PARENTS TO USE THIS DEVICE
AND HOW QUICKLY COULD WE GO
TO TITRATE IN SLEEP APNEA.
SO INITIALLY OUR SUCCESS
RATE WAS JUST SHY OF
70 PERCENT, DEFINING A
DECREASE IN THE AHI TO
50 PERCENT OR MORE.
AS WE HAVE LEARNED MORE
ABOUT THIS, WE ARE JUST SHY
OF 90 PERCENT THAT WE HAVE A
SUCCESS RATE OF THIS MEASURE
NOW THAT WE HAVE CHANGED THE
TITRATION SETTINGS.
BUT WHILE WE WERE DOING
THIS -- THE FIRST STUDIES WE
WERE DOING IS TO SAY IS THE
DEVICE SAFE AND EFFECTIVE
DEFINED BY A CHANGE IN THE
API INDEX.
BUT WHILE WE WERE DOING THIS
STUD HE COULD, PARENTS CAME
TO US, WHICH IS WHY I SAY
RESTORE VERSUS RESTORY, TO
LISTEN TO THE PARENTS AND IN
THIS STORY, THE PARENTS
THINK SHE IS A DIFFERENT
KID, CONNECTING WITH THINGS
AROUND HER, A CHILD'S SPEECH
COULD BE UNDERSTOOD IN
SCHOOL.
SO WE DID SMALL NESTED
STUDIES IN THE PRIMARY STUDY
WE WERE DOING, FIRST JUST TO
SAY OF CAREGIVERS, HOW MANY
CAREGIVERS WERE REPORTING
THERE WAS NEUROCOGNITIVE AND
EXPRESSIVE LANGUAGE TESTING.
COULD THIS BE LOOKED AT.
AND WHEN THIS CAME UP, OUR
NOW CURRENT STUDY, THIS IS
QUALITATIVE AND EXPLORATORY
WORK BUT NOT ONLY WERE WE
FINDING CHANGES IN THE
NEUROCOGNITIVE EXPRESSIVE
LANGUAGE TESTING, THIS IS
FOR KIDS WHOSE AHI WAS STILL
GREATER THAN 10.
AND THIS WAS REALLY
IMPORTANT BECAUSE A PRIOR
WORK HAS SUGGESTED YOU WANT
TO GET THAT AHI UNDER 2 OR
YOU COULD HAVE A DETRIMENT
IN YOUR IQ. AND I THINK
THIS IS REALLY THE WORLD
THAT WE'RE GOING TO LEARN SO
MUCH MORE IN OVER THE NEXT
FIVE YEARS AS TO WHAT
ACTUALLY WE SHOULD BE
SHOOTING FOR, IS IT THE AHI
OR ARE THERE OTHER MEASURES
WE SHOULD BE LOOKING AT.
WHEN YOU LOOK AT THE
POPULATION, AGAIN THESE ARE
THE BASIC PRELIMINARY DATA
TO SUGGEST THAT, YEAH, THERE
WERE INCREASES IN MEASURES
OF INTELLIGENCE AND
VOCABULARY TENSION EVEN IN
THESE KIDS WHO HAD MODERATE
SLEEP APNEA BUT THE CHANGED
BEEN SO DRAMATICALLY
AFFECTED.
AND THERE IS A WONDERFUL
SPEECH PATHOLOGIST IN UC
DAVIS WHO HAD VALIDATED
EXPRESSIVE LANGUAGE SCORES
FOR CHILDREN WHO HAD DOWN
SYNDROME.
LOOKING AT THESE AS A NUMBER
OF TOTAL UTTERANCEO OR
UNDERSTANDABLE UTTERANCES
AND THIS WENT UP IN THIS
POPULATION.
SO WE KNEW FROM OUR POSITIVE
WORK THAT MAYBE THE DEVICE
CERTAINLY DID WORK TO
DECREASE A CHILD'S SLEEP
APNEA AND LIMIT THEIR NEED
TO HAVE CPA P BUT THERE WAS
SOME SUGGESTION THERE WERE
NEUROCOGNITIVE AND
EXPRESSIVE LANGUAGE CHANGES
AND THAT IS REALLY WHAT HAS
GOT TEN TO OUR STUDY NOW
WHERE THE QUESTION IS DOES
HYPOGLOSSAL NERVE
STIMULATION AFFECT
CHILDREN'S LANGUAGE AND
SLEEP APNEA.
IF THAT IS TRUE, THEN THIS
CONNECTION OF HOW YOU LIVE
YOUR NIGHTS AFFECTS HOW YOU
LIVE YOUR DAY IS GOING TO BE
SOMETHING WE LOOK VERY, VERY
CAREFULLY AT WITH MOOD,
ATTENTION AND SPEECH.
AND YOU KNOW EVERY TEST,
EVERY STUDY YOU DO, YOU HAVE
TO THINK ABOUT WHAT YOUR
INCLUSION CRITERIA ARE AND
THERE ARE -- WE CERTAINLY
COULD DEBATE AROUND THE
EDGES IN TERMS OF WHERE WE
LOOK, WE USE THE SAME
CRITERIA WE HAD DONE IN
PRIOR STUDIES AND THERE
WOULD BE QUESTIONS OF SHOULD
WE BE INCLUDING PATIENTS WHO
IS API IS SLIGHTLY HIGHER,
LIKE THE ADULTS WE HAVE
STUDIED WHO ARE OVER 65 OR
EVEN 100, WHETHER BMI,
SHOULD IT BE AN INCLUSION OR
EXCLUSION CRITERIA OR SHOULD
IT BE BASED SLOWLY ON THE
SLEEP ENDOSCOPY OR BASED ON
KIDS WHO HAVE SLIGHTER AHI
AND ARE FINE WITH CPA P BUT
THESE ARE THE QUESTIONS AND
WHAT WE'RE LOOKING AT.
THESE KIDS ARE GETTING SLEEP
STUDIES AT THE 1, 3, 6 AND
12 MONTHS AND GETTING
EXPRESSIVE AND LANGUAGE
TESTING AT 3, 6 AND 12
MONTHS AND THOSE ARE THE
OUTCOMES OF OUR STUDIES.
AGAIN, YOU KNOW, I KEEP
GOING BACK TO THE CHILDREN
OF THE PARENTS IN TERMS OF,
YES, THE OUTCOMES WE ARE
LOOKING AT IS NEUROCOGNITION
AND EXPRESSIVE LANGUAGE IN
TERMS OF THAT THEY ALLOW US
TO HAVE VALIDATED MEASURES,
HAVE SAMPLE SIZE, APPLY
RIGOROUS SCIENCE BUT THERE
IS A HUMAN FACE TO IT.
THE GOAL IS FOR THESE KIDS
TO BE ABLE TO NOT JUST SERVE
BUT TO LIVE THEIR LIFE IN A
RICHER WAY AND EMPOWER THEM
TO GO TO SCHOOL AND
TRANSITION FROM SCHOOL AND
THEIR PARENTS' LIVES TO
THEIR OWN LIVES AS THEY
BECOME ADULTS AND FOR THEIR
LIVES TO BE CHANGED THIS WAY
SO THIS IS THE REASON WE DO
THIS AND WE WORK TOGETHER.
SO I WILL END THERE AND OPEN
IT UP TO QUESTIONS BUT FOR
THOSE -- YOU KNOW, FEEL FREE
TO E-MAIL ME AFTERWARDS FOR
QUESTIONS.
I DID WANT TO SHOW THAT JUST
ON YOUTUBE AND ON OUR
WEBSITE, WE DO HAVE --
CREATED MULTILINGUAL AND
CARTOONS BASICALLY THAT
PARENTS HAVE HELPED INFORM
US WOULD BE HELPFUL FOR
THEIR CHILDREN AND FOR
THEMSELVES IN TERMS OF
EXPLAINING WHAT THE ACTUAL
DEVICE IS AND HOW IT WORKS
AND WHAT HAPPENS AFTER, AS
WELL AS TO EXPLAIN WHAT A
SLEEP STUDY IS BECAUSE FOR
MANY OF THESE KIDS, IT IS
NOT THE SARSERVER THAT IS
THE HARDEST PARDON, IT IS
ALL THE WIRES AND
PREPARATION FOR THE SLEEP
STUDY I THINK IS SOMETIMES
AS IMPORTANT AS THE
PREPARATION FOR THE SURGERY
ITSELF.
AND I ALSO JUST WANTED TO
SAY THAT I AM NOT A FACEBOOK
USER BUT ONE OF THE
WONDERFUL MOMS OF A CHILD
WHO UNDERWENT A CHILD WITH
HYPOGLOSSAL IMPLANTATION HAS
A SHARED PARENT PAGE, A
CLOSED GROUP, SO THAT
PARENTS WHO ARE EITHER
THINKING ABOUT THIS
PARTICULAR SURGERY OR HAVE
HAD THE SURGERY, WHAT IS IT
LIKE WHEN THEY GO HOME AND
HAVE QUESTIONS AND HAVE
OTHER PEOPLE EXPERIENCED
THAT.
I THINK THAT IS A REALLY
WONDERFUL RESOURCE FOR
PARENTS WHO ARE CONSIDERING
THIS FOR THEIR CHILDREN.
SO WITH THAT, I AM GOING TO
STOP AND OPEN IT UP FOR
QUESTIONS.
AND THANK YOU.
AND MAYBE I WILL STOP
SHARING.
>> THANK YOU, CHRIS, WE
APPRECIATE IT AND WE WILL
ACTUALLY TAKE QUESTIONS AT
THE VERY END, AFTER I HAVE A
CHANCE TO INTRODUCE
MS. DOMINGUEZ AND SHE CAN
SHARE HER EXPERIENCE AS WELL
AND WE ENCOURAGE ALL
PARTICIPANTS TO ENTER
QUESTIONS IN THE Q&A
FUNCTION AND AFTER WE
INTRODUCE MS. DOMINGUEZ WE
WILL OPEN UP THE FLOOR FOR
Q&A FROM THE GROUP.
SO ONCE AGAIN, THANK YOU
Dr. HARTN ICK FOR A
WONDERFUL PRESENTATION AND
IT IS MY GREAT PLEASURE TO
INTRODUCE MS. LOIDA
DOMINGUEZ, THE MOTHER OF A
19-MONTH OLD YOUNG MAN.
HER SON WAS BORN WITH DOWN
SYNDROME AND HE IS THE LIGHT
OF HER LIFE.
SHE IS A LOVING MOTHER THAT
CREATES CHANGE IN THE WAY
THAT PEOPLE PERCEIVE
INDIVIDUALS FOR EXTRA
SUPPORT.
SHE OFFERS A PERSPECTIVE OF
UNCONDITIONAL LOVE AND IS
COMMITTED TO THAT JOURNEY.
SHE IS A LIFE COACH, MENTOR,
SINGER, SONG PRIORITY AND
PUBLISHED AUTHOR.
SHE USES ALL OF THESE TOOLS
TO BETTER SUPPORT PEOPLE TO
AWAKEN TO DO HER LAYERS OF
LOVE WITHIN THE CELLS.
NOTABLY, MS. DOMINGUEZ IS
ALSO A --
[INDISCERNIBLE]
AND SUPPORTS THE WELL-BEING
OF ANIMALS AND THE WORLD AS
A WHOLE.
SHE IS DEVOTED TO BEING THE
CHANGE SHE WANTS TO SEE IN
THE WORLD AND IS COMMITTED
TO LEAVING THE WORLD A
BETTER PLACE THAN WHEN SHE
JOINED IT.
THANK YOU, WE APPRECIATE YOU
BEING HERE TODAY.
SO WE HAVE A FEW QUESTIONS
FOR YOU.
Dr. HARTNICK WENT THROUGH
THE STUDY AND THE RESULTS.
COULD YOU TELL US A LITTLE
BIT ABOUT HOW YOU LEARNED
ABOUT THE STUDY AND WHY YOU
DECIDED TO PARTICIPATE?
>> YES, FIRST I WANT TO SAY
THANK YOU FOR HAVING ME.
I LOVED JUST LISTENING TO
Dr. HARTNICK'S EXPLANATION
AND I THINK THAT WILL BE
BENEFICIAL FOR PEOPLE
THINKING OF GETTING THIS
SYSTEM FOR THEIR CHILDREN
AND I WANT TO EMPHASIZE MY
THANKS FOR HIM FOR BEING
HERE AND THANK YOU ALL FOR
CREATING THIS SPACE.
I HEARD ABOUT THE STUDY FROM
Dr. HARTNICK AND MY DESIRE
TO DO THE STUDY IS I AM
ALWAYS OPEN TO STUDIES
BECAUSE I FEEL LIKE THEY ARE
BENEFICIAL TO PEOPLE WHO ARE
THINKING OF GETTING THIS
DONE IN THE FUTURE, TO
ACTUALLY GET SOMETHING SOLID
OF WHAT ARE THE BENEFITS.
LIKE IS MY SON GONNA LEARN
BETTER OR SPEAK BETTER AND
PEOPLE CAN THEN SEE, YOU
KNOW, THE OUTCOME ISN'T ONLY
YOUR CHILD WILL SLEEP BETTER
BUT THEY MAY LEARN BETTER,
BE ABLE TO FOCUS BETTER, BE
BETTER, SO I JUST WANTED TO
DO THE STUDY BECAUSE I KNOW
IT WOULD SERVE MORE THAN
JUST US.
>> PERFECT, THANK YOU SO
MUCH.
SO YOU TALKED A LITTLE BIT
THAT Dr. HARTNICK INVITED
YOU TO JOIN THE STUDY.
CAN YOU TELL US SO FAR WHAT
YOUR EXPERIENCES HAVE BEEN
WITH THE STUDY AND
INTERACTING NOT ONLY WITH
Dr. HARTNICK BUT THE REST
OF THE RESEARCH TEAM?
STPWHRAOEU FEEL LIKE IT HAS
BEEN A SHORT-LIVED PROCESS
BECAUSE IT WASN'T THAT LONG
AGO THAT MY SON HAD SURGERY
BUT ONE OF THE THINGS THAT I
HAVE APPRECIATED IS THAT I
HAVEN'T FELT LIKE IT'S A LOT
OF OTHER THINGS THAT I NEED
TO DO BECAUSE I ALREADY HAVE
A LOT ON MY PLATE SO THE
THOUGHT OF, YOU KNOW,
SIGNING UP FOR A STUDY THAT
MAYBE I AM GOING TO HAVE TO
GO TO 25 APPOINTMENTS AND
LIKE I AM HAVING A HARD TIME
BREATHING, IT HAS NOT BEEN
LIKE THAT.
THE APPOINTMENTS HAVE BEEN
SET GRADUALLY AND IT'S A
BREATHABLE PROCESS.
THERE IS SPACE IN BETWEEN SO
I HAVE APPRECIATED THAT.
>> SO IT SOUNDS LIKE YOU
HAVE THE OPPORTUNITY NOT
ONLY BECAUSE WE DO HEAR THAT
A LOT, THAT IT IS A BURDEN,
A LOT TO ASK FOR YOU TO COME
IN MULTIPLE TIMES BUT IT
SOUNDS LIKE THIS IS, YOU
KNOW, ONCE YOU HAVE THE
SURGERY AND THE TIME PERIOD
THAT Dr. HARTNICK OUTLINED
FOR THE POST-OP, IT IS
WORKING OUT WELL FOR YOU AND
WHAT YOU HAVE TO MANAGE WITH
YOUR LOVED ONE.
>> YES, AND ANOTHER THING I
WANT TO MANSION IS BECAUSE I
AM DOING THIS FOR IN SERVICE
TO SOMETHING GREATER, THEN
THE OBSTACLE OF DON'T BECOME
SO STRONG BECAUSE WHEN I
HAVE -- WHEN SOMETHING IS
IMPORTANT TO ME, THEN THE
OBSTACLES -- IT IS LIKE NO,
THIS IS A COMMITMENT I MADE
AND IT IS FOR SOMETHING
GREATER AND I AM GOING TO
FIGURE IT OUT NO MATTER
WHAT.
>> YEAH, AND THAT IS AMAZING
BECAUSE IT SOUNDS LIKE IT IS
THE BENEFITS NOT ONLY FOR
YOUR SON AND YOU BUT FOR THE
SCIENTIFIC RESEARCH TO THE
LARGER COMMUNITY AS WELL,
JUST TO GET THE DATA.
SO CAN YOU SPEAK TO YOUR
SON'S EXPERIENCE SO FOR
WITHIN THE STUDY AND WHAT
ARE SOME OF THE THINGS HE
HAS ENJOYED, WHAT ARE SOME
OF THE CHALLENGES OR THINGS
THAT HAVE NOT BEEN AS
PLEASANT AND THE EXPERIENCE?
>> WHEN YOU THINK ABOUT THE
STUDY, YOU MEAN WITH THE
MACHINE ITSELF?
>> YES, THE DEVICE ITSELF.
>> OKAY, UM IT HAS BEEN
INTERESTING BECAUSE MY SON
IS 19 SO I FEEL LIKE MAYBE
WHEN A CHILD IS YOUNGER,
MAYBE THEY WILL NOT NOTICE
THE DIFFERENCE AS MUCH BUT
BECAUSE MY SON IS 19, HE
NOTICES, OKAY, THIS MACHINE
GOES ON AND ALL OF A SUDDEN,
MY SON IS MOVING.
SO IT HAS BEEN A PROCESS
BECAUSE SOMETIMES HE IS NOT
ASLEEP WHEN IT TURNS ON.
SOMETIMES HE TAKES LONGER TO
FALL ASLEEP SO EVEN IF I
HAVE IT SET FOR 30 MINUTES,
HE IS NOT ASLEEP AND, YOU
KNOW, HIS TONGUE IS MOVING.
AND HE IS -- MY SON IS THE
CUTEST.
SO HE STARTS MESSING WITH IT
AND I ASK IS THE MACHINE
BOTHERING YOU AND HE SAYS NO
SO THAT GIVES ME PEACE TO
KNOW THAT IT IS NOT
BOTHERING HIM, IT IS JUST
SOMETHING DIFFERENT AND NEW.
TYPICALLY WE MOVE OUR OWN
TONGUES BUT WHEN THIS
MACHINE IS ON, IT IS MOVING
HIS TONGUE FOR HIM SO IT IS
A PROCESS OF HIM GETTING
USED TO IT WHEN HE IS AWAKE
BUT OVERALL, IT HAS BEEN
GOOD, YEAH.
>> AMAZING.
SO ONE OF THE BENEFITS, AND
I KNOW DOCTOR HARTNICK
TALKED ABOUT WITH WITH
REGARD TO SOME OF THE PILOT
DATA, THE ANECDOTAL
REPORTING BACK FROM PARENTS
IS THEY HAD SEEN IMPROVEMENT
IN JUST OVERALL WELL-BEING,
ABILITY TO RECALL WORDS AND
JUST PEOPLE'S MOODS.
HAVE YOU SEEN ANY BENEFITS,
AND I KNOW THIS IS VERY
EARLY AS WELL IN THE STUDY
BUT HAVE YOU SEEN ANY
BENEFITS SO FAR?
>> WELL, I HAVE HEARD FROM
SCHOOL IN THE LAST COUPLE OF
WEEKS THAT THEY HAVE BEEN
ABLE TO UNDERSTAND HIM A
LITTLE BETTER, WHICH I THINK
IS A RESULT OF THIS PROCESS.
MY SON ALSO DID HAVE A
SURGERY PRIOR TO THIS WHICH
WAS TO REDUCE HIS TONGUE
BUT -- SO I THINK THAT
HELPED HIM BE A LITTLE MORE
CLEAR, TOO.
BUT SO I THINK THAT IS A
PLUS.
THIS IS A TONGUE REDUCTION
BUT IF HIS TONGUE WAS
GETTING IN THE WAY OF HIM
BEING ABLE TO JUST SPEAK
CERTAIN WORDS AND BE
UNDERSTOOD, IF THIS MACHINE
IS HELPING HIM GET THE REST
THAT HE NEEDS IN ORDER FOR
HIM TO THINK AND BE MORE
PRESENT IN SCHOOL SO THAT HE
CAN LEARN, THOSE ARE PLUSES
AND SO FOR ME TO HEAR FROM
THE SCHOOL OVER THE LAST
COUPLE OF WEEKS THAT THEY
HAVE BEEN ABLE TO UNDERSTAND
HIM MORE AND HE SEEMS A
LITTLE MORE SETTLED, IS
EXCITING TO ME BECAUSE THIS
IS JUST THE BEGINNING.
>> ALL RIGHT, AND Dr.
HARTNICK CAN SPEAK TO THAT.
I KNOW WE ARE ALWAYS
PRESENTING THE POSITIVE SIDE
BUT I THINK IT IS REALLY
IMPORTANT TO SEE A
WELL-ROUNDED PICTURE AND
OBTAIN A WELL-ROUNDED
PICTURE.
HAVE THERE BEEN CHALLENGES
AT ALL WITH REGARD TO THE
DEVICE OR JUST IN TERMS OF
BEING OPEN?
AND IF THERE AREN'T ANY,
WONDERFUL, WE DEFINITELY
DON'T WANT TO CREATE ONE
WHERE THERE ISN'T.
>> YEAH, I THINK THE ONE
THAT I MENTIONED WHERE, YOU
KNOW, SOMETIMES HE IS JUST
LIKE WEIRDED OUT ABOUT THE
TONGUE BUT I DON'T THINK
THAT'S A HUGE -- I THINK
THAT'S JUST A NORMAL ONE.
I DID WANT TO MENTION THAT
THERE WAS AN APPOINTMENT --
I WENT TO A STUDY AND THIS
WAS ONE OF THE FIRST STUDIES
AND FOR WHATEVER REASON, ONE
OF THE MACHINES DIDN'T WORK
AND SO WHATEVER TESTING HE
HAD TO TAKE, THEY WEREN'T
ABLE TO GET IT SO THEY
CALLED ME TO RESCHEDULE
WHICH FELT LIKE I HAVE TO GO
BACK INTO BOSTON, LIKE IT IS
OVER 30 MINUTES AND ON A
WORKING DAY, IT IS AN HOUR,
LIKE WHAT THE HECK.
BUT WHAT I DID APPRECIATE IS
THAT Dr. HARTNICK AND THE
STUDY TEAM, THE TEAM, WORKED
TOGETHER IN ORDER FOR ME TO
BE ABLE TO COME IN AND SEE
Dr. HARTNICK ON THE SAME
DAY TO GET THE MACHINES
TURNED ON AND THEN IT WAS A
10-MINUTE PROCESS FOR ME TO
GO THROUGH THE STUDY TO GET
THESE QUESTIONS ASKED.
SO IT WASN'T LIKE OH MY GOD,
I HAVE TO GO TWICE, LIKE
THEY WORKED TOGETHER AND I
APPRECIATE THAT THEY SEE ME
AS A PARENT AND WORKED
TOGETHER TO MAKE A SMOOTH
PROCESS.
>> NOT ONLY AS A PARENT BUT
PART OF THE STUDY, RIGHT,
BECAUSE AGAIN, WE WOULDN'T
BE ABLE TO GET THE DATA
WITHOUT PARTICIPANTS LIKE
YOURSELF AND WITH NICHOLAS.
SO JUST IN TO THAT, I THINK
ALSO THERE IS A RESEARCH
TEAM THAT WORKS WITH YOU AND
NOT NECESSARILY WORKING WITH
YOUR SCHEDULE, RIGHT?
SO ARE THERE SOME
SUGGESTIONS YOU HAVE WITH
FUTURE STUDIES?
>> I WROTE SOME NOTES.
JUST BE AWARE THAT PEOPLE
LIVE IN DIFFERENT PLACES AND
CONSIDER PEOPLE'S TIME SO
THAT YOU ALL ARE
ACCOMMODATING PARENTS AND
THAT THIS DOESN'T BECOME A
STRESSFUL PROCESS.
AND THAT THE PROCESS, WE
KNOW IT IS GOING TO SERVE
FOR THE FUTURE.
SO THAT -- BECAUSE IF THE
FOCUS BECOMES ON MY STRESS,
THEN IT IS LIKE AGH, IT IS
LIKE WE'RE MISSING THE POINT
HERE.
SO IF PEOPLE CAN JUST THINK
AND CONSIDER PARENTS'
SCHEDULES AND THEIR ADDED
STRESS AND DO WHAT WAS DONE
FOR ME ESSENTIALLY, WHAT WAS
DONE FOR ME WAS LIKE WE GOT
YOU.
YOU KNOW, YOU MADE A
COMMITMENT TO DO SOMETHING
AND WE GOT YOU, WE'RE NOT
TRYING TO MAKE THIS MORE
CHALLENGING THAN IT HAS TO
BE, YOU CAN COME IN A AWOKE
TO SEE Dr. HARTNICK AND
COME HERE AND YOU ARE DONE.
THANK YOU, THANK YOU SO
MUCH.
[LAUGHTER]
>> AND I CAN IMAGINE BECAUSE
D.C. TRAFFIC IS HORRIBLE.
ONE MORE QUESTION, I KNOW
INVOLVED AS AN ARTIST.
CAN YOU TELL ME YOUR
MOTIVATION BEHIND WRITING
YOUR BOOK AND IF YOU HAVE AN
EXAMPLE OF YOUR BOOK NEARBY,
I WOULD LIKE YOU TO SHARE IT
BUT JUST TELL US THE
MOTIVATIONS BEHIND YOUR
BOOK.
>> THANK YOU, THANK YOU FOR
ASKING.
I WILL SHOW YOU MY BOOK REAL
QUICK.
SO THE NAME IS "AWAKENED
WINNERS" AND THE SUBTITLE IS
WE ALREADY WON.
AND THIS IS A PICTURE OF MY
BEAUTIFUL SON, LIKE I AM
JUST OBSESSED WITH HIM.
SO MY MOTIVATION IN WRITING
A BOOK, SO MY EXPERIENCE
AFTER I HAD NICHOLAS WAS
VERY INTERESTING TO ME
BECAUSE I NEVER FELT GRIEF
AROUND HIS DIAGNOSIS, BUT
WHAT I EXPERIENCED WAS OTHER
PEOPLE PROJECTING THAT
SOMETHING WAS REALLY BAD,
LIKE YOU KNOW PEOPLE WOULD
SAY THINGS LIKE WHY DO YOU
THINK THAT HAPPENED TO YOU,
YOU ARE SUCH A GOOD PERSON
AND I STILL HAVE A HARD TIME
SAYING THAT BECAUSE IT JUST
BREAKS MY HEART.
OR DO YOU THINK THAT
HAPPENED TO YOU BECAUSE OF
HIS DAD OR YOU, JUST IT WAS
FIGURING OUT HOW THIS ERROR
OCCURRED.
BUT FOR ME, I NEVER THOUGHT
IT HAVE AS AN ERROR, I DON'T
SEE MY SON AS AN ERROR, I
THINK OF HIM AS A WHOLE
HUMAN BORN PERFECT AND
COMPLETE.
AND ONE DAY I GOT A MESSAGE
OF THE AWAKENED WINNERS AND
FELT IT WAS A DOWNLOAD TO BE
SHARED WITH THE WORLD.
NOT ONLY TO EXPRESS THAT MY
SON IS A WINNER LIKE WE ALL
ARE BUT TO HELP PEOPLE
AWAKEN TO THEIR OWN
MAGNIFICENCE BECAUSE ANYONE
WHO DOESN'T SEE MY SON'S
MAGNIFICENCE DOESN'T SEE
THEIR OWN.
>> THAT IS PROFOUND AND I
WISH I COULD --
[INDISCERNIBLE]
[LAUGHTER]
[INAUDIBLE]-- THANK YOU
AGAIN AND APPRECIATE YOUR
PARTICIPATING IN Dr.
HARTNICK'S STUDY AND AT THIS
TIME I WELCOME BACK Dr.
HARTNICK AND ASK KELLY KING
AND LAURIE RYAN TO JOIN US
AS WELL.
I OPEN IT UP TO Q&A AND SEE
THERE ARE QUESTIONS THAT
COME IN.
>> I WANT TO SAY THANK YOU
FOR THOSE BEING A PART AND
SHARING AND JUST HOW
WONDERFUL NICK IS BUT HOW
WONDERFUL BOTH OF YOU ARE
AND THESE STUDIES WORK
BECAUSE YOU ARE SUCH A
PARTICIPANT IN THE STUDY AND
IT IS A SHARED EXPERIENCE.
SO THANK YOU FOR SHARING
YOUR STORY.
>> THANK YOU SO MUCH, THANK
YOU.
>> GO AHEAD, KELLY.
>> YEAH, ABSOLUTELY, SORT OF
IN MY MOMENT OF BEING MOVED
BY MS. DOMINGUEZ' WORDS
THERE AND I SHARE IN
EVERYONE'S GRATITUDE SO WE
WILL MOVE TO THE QUESTION
AND ANSWER QUESTION, THIS IS
FOR Dr. HARTNICK OR
MS. DOMINGUEZ SO FEEL FREE
TO PUT YOUR QUESTIONS IN THE
Q&A AND WE SHOULD BE ABLE TO
GET TO ALL OF THEM.
SO Dr. HARTNICK, COULD YOU
REVISIT THE AGE CRITERIA FOR
PARTICIPATING IN THE STUDY?
>> SO THE AGE CRITERIA IS
FOR KIDS 10-21 AND IN THE
STUDY ITSELF.
IT IS IMPORTANT FOR
PEOPLE -- WHEN WE STARTED
THIS STUDY THIS WAS NONFDA
APPROVED FOR THAT AGE
POPULATION.
AS OF WORLD ALDERMEN LAST
YEAR, PART OF THE WORK WE
COULD HAVE DONE, IT IS NOW A
FDA-APPROVED DEVICE FOR THIS
POPULATION OF KIDS AGE 1313.
1 3 -- AGE 13.
BUT FOR KIDS UNDER 13, IT
WAS NOT APPROVED TO BE
IMPLANTED -- [ INDISCERNIBLE
].
[INAUDIBLE]
>> THAT TIES INTO ANOTHER
QUESTION THAT WAS ASKED
WHETHER WE ANTICIPATE THE
CHILDREN YOUNGER THAN 10 MAY
EVENTUALLY BE ABLE TO HAVE
THAT IMPLANTATION IF THEY
MOOT -- MEET THE CRITERIA
AND WHY OR WHY NOT YOU MAY
MAKE THAT PREDICTION?
>> SO MANY PARENTS ASK THAT.
I AM OLD ENOUGH TO HAVE BEEN
PART OF THE COCHLEAR IMPLANT
EXPERIENCE WHERE WE STARTED
OLDER AND WORKED OUR WAY
YOUNGER, WE WANTED TO BE
SAFE AND IMPROVE SAFETY.
WE HAVE IMPLANTED A
4-YEAR-OLD WITH DOWN
SYNDROME WHOSE PARENTS ARE
JUST AS LOVELY AS CAN BE AND
WERE SUFFERING TERRIBLY.
SO I KNOW, A, HAVING DONE
IT, THE HYPOGLOSSAL IS BIG
ENOUGH FOR KIDS TO HAVE THAT
IMPLANTATION AT A FAR
EARLIER AGE.
I HAVE STRONG FEELINGS IT
WILL BE IMPLANTED OVER TIME
BECAUSE THERE ARE SO MANY
YEARS OF KIDS BEING ABLE TO
HAVE INCREASED NEURO-- IT IS
TRUE THAT THEY CERTAINLY
WILL SLEEP BETTER AND HAVE
BETTER NEUROCOGNITION AND
EXPRESSIVE LANGUAGE.
SO I THINK WE ARE IN EARLY
DAYS BUT WE HAVE TO WORK
TOGETHER SLOWLY AND SAFELY
AND WELL AND LEARN FROM OUR
EXPERIENCE AS WE GO SLOW.
SO I THINK THAT IS MY SUPER
LONG-WINDED WAY OF SAYING
YES, IT WILL HAPPEN EARLIER,
JUST IN SMALL BABY STEPS.
>> SO WE HAVE AN AUDIENCE
MEMBER SHARE THAT THEIR SON
WHO WILL TURN 6 NEXT MONTH
ALREADY HAD ONE SLEEP STUDY
AND IT WAS A TERRIBLE
EXPERIENCE.
THEY DID WIND UP REMOVING
THEIR TONSILS AND ADENOIDS
BUT HE IS STILL RESTLESS AND
TOSSES AND TURNS ALL NIGHT
AND IS A SUPER LINE LIGHT
SLEEPER.
THEY ARE INTIMIDATED AND
SCARED OF ANOTHER SLEEP
STUDY AND CURIOUS IF YOU
HAVE ANY ADVICE FOR HOW TO
GET A BETTER OUTCOME OR
BETTER PREPARATION FOR NOT
ONLY THE CHILD BUT THE
FAMILY IF THEY WERE TO ENTER
ANOTHER STUDY.
>> FIRST OF ALL, HOPEFULLY
THAT CARTOON HELPS A LITTLE
BIT.
MOST LABS ALLOW THE KIDS TO
TOUR THE LAB IF THAT IS
HELPFUL AT ALL BUT I FEEL
AND SHARE YOUR PAIN.
IT IS A LOT OF WIRES, IT
REALLY IS.
AND SOMETIMES IT IS HARD TO
HAVE A SLEEP LAB AND SLEEP
STUDY AS A CHILD WHETHER OR
NOT THEY HAVE DOWN SYNDROME
OR NOT AND HARD TO BE A
PARENT DURING A SLEEP STUDY
AS WELL SO I KNOW IT IS HARD
AND FEEL YOUR PAIN.
>> ALSO KELLY, I HAVE A
QUESTION FOR MS. DOMINGUEZ,
CAN YOU TELL ABOUT YOUR
DECISION TO PARTICIPATE IN A
SLEEP STUDY PRIOR TO Dr.
HARTNICK OR IN ADDITION TO?
>> I WAS ALREADY THINKING
BECAUSE YES, IT IS NOT A
EASY PROCESS.
AND ONE THING I MENTIONED TO
Dr. HARTNICK TOO IS MY SON
IS TYPICALLY ASLEEP BY NINE
AND FOR SOME REASON HE WAS
SCHEDULED FOR NINE FOR A
SLEEP STUDY AND I WAS LIKE
NO, BECAUSE BY THE TIME THEY
GOT THE WIRES ON MY SON, IT
WAS 10:00 AND MY SON WAS
EXHAUSTED AND I WAS VERY
UPSET AND I WAS LIKE THIS IS
NOT IT.
SO NOW THEY ARE MAKING IT A
POINT TO MAKE SURE THE
APPOINTMENTS ARE SET AT
EIGHT BUT YES, THAT IS A LOT
OF WIRES TO BE PLACED ON
HIM.
HE IS NOT SLEEPING THE WAY
HE WOULD SLEEP AT HOME,
RIGHT?
LIKE HE IS NOT COMFORTABLE,
LIKE, WITH THESE THINGS ON
HIS HEAD.
SO HE HAS HAD A LOT OF SLEEP
STUDIES SO I FEEL LIKE HE IS
KIND OF USED TO THE PROCESS
BUT IT IS STILL NOT
COMFORTABLE.
SO I TOTALLY FEEL COMPASSION
FOR CHILDREN OR ADULTS AND
PARENTS GOING THROUGH THIS
PROCESS.
>> BUT I THINK AS YOU
MENTIONED, Dr. HARTNICK
AND HIS TEAM WAS WILLING --
GIVEN THE EXPERIENCE THAT
YOU HAD THAT WAS NOT
NECESSARILY PLANET THE FIRST
TIME, THEY WERE WILLING TO
WORK WITH YOU TO FIND A
STUDY TEAM THAT WAS ABLE TO
WORK WITH YOU AND UNDERSTAND
YOU AND YOUR CHILD'S NEEDS
AS IMPORTANT.
>> YES, AND Dr. HARTNICK
WASN'T EVEN AWARE, RIGHT,
LIKE THERE IS SCHEDULING,
THERE IS DIFFERENT THINGS,
AND TOTALLY HE UNDERSTOOD
THAT AT 9:00, IT WOULD BE A
LOT.
BUT YES, THEY ARE NOW
WILLING TO ACCOMMODATE AND
THE SAME THING THAT HAPPENED
WITH THE OTHER APPOINTMENT,
RIGHT, LIKE I SPEAK AND
SOMETHING SHIFTS.
LIKE I HAVE TO BE MY OWN
ADVOCATE AND SAY HEY, THIS
IS NOT GOING TO WORK OR THIS
IS GOING TO WORK AND THINGS
SHIFT ACCORDINGLY TO THAT.
>> Dr. HARTNICK, ARE THERE
ANY OTHER HOSPITALS AROUND
THE COUNTRY THAT ARE ABLE TO
DO THIS SURGERY BESIDES YOUR
OWN AND ALONG WITH THAT, IS
IT POSSIBLE TO DO THE
PROCEDURE OUTSIDE OF THE
UNITED STATES OR TO LEARN
MORE ABOUT IT?
YOU HAVE ANY EXPERIENCE WITH
THIS BEING DONE GLOBALLY?
>> YEAH, IN THE STATES, THIS
IS A MULTI-- WELL ON FOR THE
STUDY ITSELF, IT IS A
MULTI-CENTERED STUDY AND
THERE ARE SITES,
PARTICULARLY IN
PHILADELPHIA, PITTSBURGH,
ATLANTA, IN CINCINNATI, AND
IN TEXAS, SO THERE ARE
MULTIPLE SITES ALONG THE
WAY.
THERE ARE CENTERS THAT
ARE -- AND TO BE CLEAR, IF
YOU ARE DEPENDING ON YOUR
FEE YO GRAPH CALL CLINIC, IF
YOU CONTACT US, WE WOULD BE
HAPPY TO DIRECT YOU BECAUSE
THE CLOSER YOU CAN BE TO
HOME, IT IS BETTER.
SO THERE ARE STUDIES
BUILDING OFF THE CENTERS AND
BUILDING EXPERIENCE.
I KNOW THEY ARE DOING THE
FIRST IMPLANTATIONS IN
ENGLAND NEXT WEEK WITH A
WONDERFUL GROUP ON NORMAL
STREET AND I KNOW I HAVE
BEEN INVOLVED WITH THE
BEGINNINGS OF THE PROGRAM IN
SINGAPORE SO IT IS GAINING
TRACTION ELSEWHERE BUT IT IS
IN TERMS OF LITTLE STEPS.
>> I WAS GOING TO SAY Dr.
HARTNICK, WE MAY HAVE TO
DISTRIBUTE YOUR E-MAIL TO
THE GROUP BECAUSE THERE IS
DEFINITELY INTEREST IN
LEARNING MORE ABOUT THAT AS
WELL.
>> SURE.
>> THIS IS A GOOD QUESTION
FOR BOTH Dr. HARTNICK AND
MS. DOMINGUEZ, CAN YOU TALK
ABOUT THE ONGOING WORK WITH
THE DEVICE AND WHAT PARENTS
HAVE TO DO EVERY DAY?
>> YOU WANT TO GO FIRST AND
I WILL GO SECOND?
>> WELL, FOR ME, AS A
PARENT, THERE IS NO
MAINTENANCE REALLY.
EVERYTHING IS SELF
EXPLANATORY.
LIKE YOU LITERALLY PRESS A
BUTTON.
I EVEN GIVE THE MACHINE TO
MY SON AND HE PUTS IT ON HIS
CHEST, IT MAKES A SOUND, IT
TURNS ON AND THEY PROGRAM IT
SO THAT IT IS SHUTTING OFF
AFTER A CERTAIN AMOUNT OF
HOURS AND IF HE WAKES UP
BEFORE THAT TIME, THERE'S A
BUTTON I CAN PRESS SO I CAN
SHUT IT OFF MYSELF.
IT IS A PRETTY SIMPLE
PROCESS.
I THINK THAT THERE'S --
BECAUSE THIS WAS A QUESTION
I HAD AND MAYBE THIS WILL
BRING CLARITY, TOO, IS THAT
IT HAS TO BE REPLACED,
RIGHT, AND LIKE HOW MANY
YEARS AFTER HE HAS IT DOES
IT HAVE TO BE REPLACED.
>> RIGHT, SO IT DOES HAVE A
REMOTE CONTROL AND IT IS
TRUE THAT, YOU KNOW, AT
FIRST BEFORE WE USED REMOTE
CONTROL DEVICES, IT WAS AN
ON AND OFF BUTTON.
AND THIS IS A SIMPLE DEVICE,
WITH UP AND DOWN AND NOT ALL
THE THINGS YOU HAVE ON A
NORMAL TV REMOTE.
IT DOES HAVE BATTERIES AND
FLASHES A LIGHT WHEN IT
NEEDS REPLACEMENT.
AND IN THE PACEMAKER, THERE
IS AN INTERNAL BATTERY WHICH
IS A SAME DAY PROCEDURE SO
THE PROCESSOR CAN BE
CHANGED.
I THINK SO FAR I HAVE
CHANGED FIVE IN KITS
INPLANTED SINCE 201 OR THAT
GROUP.
SO WE THINK THE BATTERY WILL
LAST SOMEWHERE BETWEEN 10 OR
15 YEARS, WE HOPE THERE WILL
BE RECHARGEABLE BATTERIES BY
THEN.
SEEMS LIKE WITH ALL
PACEMAKERS, THEY CHANGE WITH
TIME BUT THAT PROCEDURE IS
NOT AT ALL LIKE THE FIRST
PROCEDURE WHICH IS ABOUT AN
HOUR AND A HALF PROCEDURE.
IT IS A PROCEDURE BUT IT IS
SHORTER AND ABOUT EVERY 10
TO 15 YEARS.
>> SO I THINK THAT CUES UP
THE NEXT QUESTION, YOU
TALKED ABOUT THE
LONGITUDINAL EXPERIENCE
PATIENTS HAVE HAD THAT HAVE
BEEN IMPLANTED.
DO YOU HAVE EXPERIENCE WITH
WAITERS WHO ARE TWO YEARS OR
MORE AND I THINK YOU HAVE
TALKED ABOUT THAT BUT CAN
YOU TALK ABOUT THE LONG-TERM
USE OF THE DEVICE, IF THERE
HAVE BEEN ANY LESSONS
LEARNED, ANY PROBLEMS THAT
CROPPED UP, YOU KNOW, THE
GENERAL MAINTENANCE AND
SUSTAINABILITY OF IT,
ANYTHING LIKE THAT?
>> YEAH, WELL, I THINK THAT
WE HAVE PUBLISHED ON THIS
AND WE HAVE LOOKED AT AT
LEAST THE 5-YEAR EXPERIENCE
FOR A BUNCH OF KIDS WHO WERE
10-13 AND THIS WAS THE PART
OF THE STUDY WHERE WE WERE
STILL IMPLANTING REPUBLICANS
SORE -- IMPLANTING THE
SENSOR UNDER THE NIPPLE AND
WORRIED ABOUT THROUGH TIME,
HOW WOULD THAT DO AS KIDS
GREW AND EVEN THEN THERE WAS
THINKING THAT THE WIRE WOULD
GROW WITH THE KIDS SO IN
THAT SMALL EXPERIENCE OF
KIDS 10-13, I THINK IT WAS 4
1/2 YEARS OF FOLLOW UP AND
THEY WERE STABLE AFTERWARDS
WITH NO CHANGE IN THE
DEVICE.
WE HAVE NOW LOOKED AT THE
LAST 42 KIDS, IT IS
UNPUBLISHED BUT ABOUT TO BE
PUBLISHED, THEIR 5-YEAR
EXPERIENCE AND IF ANYTHING,
THEY HAVE GOT GOTTEN BETTER.
THERE ARE KIDS ONCE THEY ARE
OUT OF THE STUDY HAVE GAINED
A LOT OF WEIGHT AND WITH ANY
SLEEP APNEA WEIGHT CAN BE AN
IMPORTANT FACTOR.
SO THE SETTING MAY BE FOR A
CHILD'S CERTAIN WEIGHT AND
PHENOTYPE AND IT IS NOT IN
THOSE KIDS THAT IT DOESN'T
WORK BUT THAT THERE ARE SOME
OF THOSE KIDS WE HAVE TO GO
BACK AND REPEAT THE SLEEP
ENDOSCOPY AND AS KIDS BECOME
ADULTS, REPORT THEIR NEW
BODY HABITS AND SOME OF US
DO GET A LITTLE OVERWEIGHT
SO WE NEED TO WORK ON THAT.
THE OTHER THING WITH RESPECT
TO NICHOLAS, WITH THE SORT
OF TRANSITION, AND THIS IS
TRUE OF EVERYBODY, WHOEVER
YOUR CHILD IS, AS YOU
TRANSITION THEM TO YOU
HAVING CONTROL AND THEM
HAVING CONTROL AND GIVE THEM
THE REMOTE, SOME KIDS LIKE
THE FEELING OF THE REMOTE.
I HAD TWO PARENTS WHO SAID
THE DEVICE DIDN'T WORK AND
THE KIDS TURNED THE REMOTE
ON AND OFF ALL NIGHT LONG SO
WE HAD TO BE A LITTLE DICK
TRACY TO FIGURE THAT OUT SO
YOU LIVE AND LEARN.
>> AND TO CLARIFY WHAT YOU
ARE SAYING, THE PROBLEMS
CONNECTED TO INDIVIDUALS IS
NOT THE DEVICE THEMSELVES
BUT WAYS TO MANAGE THE
DEVICE AS YOU MOVE DOWN THE
ROAD?
>> YES, THE DEVICE HAS
NOTHING TO DO WITH GAINING
WEIGHT, IT IS JUST AS PEOPLE
DO GAIN WEIGHT, IF THE
CHILDREN GAIN WEIGHT, WE
HAVE TO MANAGE THAT OR
FACTOR THAT INTO THE ACTUAL
DEVICE AND SETTINGS.
>> IS THE EXPECTATION WHEN
PEOPLE GET THIS DEVICE
IMPLANTED THAT THEY WILL
HAVE IT FOR THE REST OF
THEIR LIVES?
>> YEAH, SUPER IMPORTANT
QUESTION.
AND THE STAR TRIAL WAS
IMPORTANT IN THAT.
BUT THIS DEVICE IS NOT -- IT
IS CURRENT WHEN THE DEVICE
IS ON.
WE HAVE LOOKED AT THAT AND
IF YOU DIDN'T TURN THE
DEVICE OFF -- EXCUSE ME, IF
YOU DIDN'T TURN THE DEVICE
ON, YOUR CHILD WOULD STILL
HAVE SLEEP APNEA.
THE REASON WE FELT
COMFORTABLE WITH CHILDREN
WITH DOWN SYNDROME IN THIS
IS WHEN YOU LOOK
LONGITUDINALLY AT CHILDREN
AND ADULTS WITH DOWN
SYNDROME, THE PHENOTYPE, THE
ACTUAL TONGUE BASE AS THE
PRIMARY SOURCE OF
OBSTRUCTION, DOESN'T SEEM TO
CHANGE OVER TIME.
WHEREAS THE CHILD WITHOUT
DOWN SYNDROME, THEY MAY HAVE
THEIR TONSILS AND ADENOIDS
OR NOT AND AS THEY BECOME
TEENAGERS, THINGS CHANGE AND
THINGS BECOME LESS OR MORE
DOMINANT.
SO THIS IS WHY WE FELT IT
WAS APPROPRIATE AND
REASONABLE DECISION FOR
IMPLANTATION IN THIS DOWN
SYNDROME POPULATION.
>> CAN YOU COMMENT ON
OVERCOMING LANGUAGE BARRIERS
FOR FAMILIES THAT DON'T
SPEAK ENGLISH IN THEIR
HOUSEHOLD AND HOW YOU ARE
ABLE TO GET INFORMATION TO
THEM NOT ONLY ABOUT THE
STUDY OR HOW THEY CAN HAVE
THEIR QUESTIONS ANSWERED
BOTH PRE-SURGERY,
POST-SURGERY, ALL THE FOLLOW
UP INVOLVED?
>> YEAH, THAT IS A GOOD
QUESTION AND WE REALLY WANT
THIS, ON THE ONE HAND,
DEVICE AND THIS THERAPY TO
BE SOMETHING THAT EVERYBODY
CAN HAVE AND REALLY TO BE
THIS -- REGARDLESS OF YOUR
LANGUAGE AND WHO YOU ARE, IT
IS JUST IF YOUR CHILD HAS
DOWN SYNDROME.
ON THE OTHER HAND, WE WANT
TO BE SURE THERE ARE
QUESTIONS THAT COME UP AND
WE WANT TO BE SURE THAT WE
HAVE -- FOR EXAMPLE, BEFORE
WE OFFERED THIS TO, AT LEAST
ON THE STUDY, FOR CHILDREN
WHO CAN SPEAK -- ARE
BILINGUAL AND UNDERSTAND
ENGLISH AND REPRODUCE IT AND
THERE ARE STUDIES OPEN FOR
THEM.
THERE IS A HOTLINE 24/7 IN
SPANISH AND ENGLISH RIGHT
NOW AND WITH THAT WE FEEL
COMFORTABLE BECAUSE PARENTS
WILL HAVE QUESTIONS AND WE
NEED TO WORK ON OTHER
LANGUAGES AS WELL.
SO IT IS A SORE POINT WE
HAVE TO KEEP WORKING ON BUT
AT LEAST IN SPANISH AND
ENGLISH, IT IS AVAILABLE AT
THIS POINT.
>> I HAVE A QUESTION OF
MS. DOMINGUEZ, KIND OF
JUMPING A LITTLE BIT IN
TERMS OF ARE THERE SOME
THINGS YOU WISH YOU WOULD
HAVE KNOWN ABOUT THE STUDY
PRIOR TO SIGNING NICHOLAS UP
AND PARTICIPATING?
>> HONESTLY I WISH I WOULD
HAVE KNOWN ABOUT IT SOONER.
I FEEL LIKE MY -- YOU KNOW,
MY SON HAD HIS ADENOIDS OUT,
TONSILS OUT, HE HAD SOME
OTHER SKIN REMOVED FROM HIS
NOSE, SOMETHING ELSE REMOVED
FROM HIS THROAT AND THEN HIS
TONGUE REDUCED, IT WAS LIKE
A LOT AND I DON'T KNOW IF,
YOU KNOW, HE WOULD HAVE
STILL HAD TO GO THROUGH ALL
OF THAT BUT I FEEL LIKE HE
WENT THROUGH A LOT OF
SURGERY THAT MAY HAVE NOT
BEEN AS NECESSARY HAD I
KNOWN ABOUT THIS DEVICE
PRIOR.
>> THANK YOU, THEN, FOR
SAYING THAT BECAUSE I THINK
THAT IS ALSO PART OF THE
REASON FOR THIS WEBINAR,
TOO, TO MAKE SURE THAT THE
HARD WORK THAT Dr.
HARTNICK AND OTHER DOCTORS
AND THE RESEARCH TEAM ARE
DOING, TO SHARE THE
INFORMATION SO MORE FAMILIES
ARE AWARE OF THE STUDIES AND
THE TRIALS.
Dr. HARTNICK MAY HAVE A
WHOLE SLEW OF INFORMATION
COMING OUT IN THE NEXT FEW
DAYS BUT YEAH, I THINK THAT
IS IMPORTANT.
>> AND GETTING A SHOUT OUT
Dr. HARTNICK, SOMEONE WAS
VERY HAPPY WITH THE STUDY,
HAD THEIR SON WHO WAS 4 WHEN
HE ENTERED THE STUDY AND
IMPLANTED AT 5 AND THEY ARE
VERY HAPPY WITH WHAT HAS
HAPPENED SO FAR --
[INAUDIBLE]
>> Dr. HARTNICK, HAVE YOU
ALL THOUGHT ABOUT THE
UNDERLYING MECHANISM,
ASSUMING THE POSITIVE
RESULTS YOU HAVE SEEN AROUND
LANGUAGE, COGNITION AND
EXPRESSIVE LANGUAGE, HAVE
YOU ALL THOUGHT ABOUT THE
MECHANISM?
I THINK ONE EASY HYPOTHESIS
TO SORT OF WRAP OUR BRAINS
AROUND IS IF YOU ARE
SLEEPING BETTER, YOU ARE
ABLE TO EXPRESS YOURSELF
BETTER BUT THE QUESTIONS
AROUND THE TONGUE, IS THAT A
CONSIDERATION?
>> YES, IT IS AN OPEN
HYPOTHESIS THAT AS WE SLEEP,
WE INCORPORATE SHORT AND
LONG-TERM MEMORY AND ARE
SORT OF RELIVING OUR DAYS TO
NOTE LESSONS LEARNED AND
HOPEFULLY GOOD AND BAD
LESSONS BUT WE CAN
MEMORIALTIZE AND INCORPORATE
THEM IN SHORT AND LONG-TERM
MEMORY, THAT WOULD MAKE
SENSE WITH WHAT WE'RE SEEING
WITH THE NEUROCOGNITIVE
CHANGES.
WITH REGARD TO EXPRESSIVE
LANGUAGE, IT IS SOMETHING WE
ARE REALLY INTERESTED IN
BECAUSE, YOU KNOW, WHETHER
THAT IS BECAUSE WE NEED
RECEPTIVE AND EXPRESSIVE
LANGUAGE ARE TIED AND
THEREFORE OUR NEUROCOGNITIVE
LANGUAGES WILL BE REFLECTED
OR BASICALLY ARE WE WORKING
OUR TONGUES MORE AND GETTING
PHYSICAL THERAPY FOR OUR
TONGUES AND I THINK THAT IS
SOMETHING WE NEED TO LOOK AT
A LITTLE BILL.
IN OTHER STUDIES, THERE HAVE
BEEN POPULATIONS OF CHILDREN
WHOA HAVE A WEALTH OF
NEUROMUSCULAR DISORDERS
WHERE PARENTS HAVE COME AND
ASK ME IF THEIR ISSUE IS
PRIMARILY FOR TONGUE BASED
OBSTRUCTION AS WELL AND
WOULD THEY BE CANDIDATES FOR
THIS.
AND WE HAVE WORRIED ABOUT
KIDS WHO ARE OBSTRUCTING ALL
DAY AND ALL NIGHT, FOR
INSTANCE WITH THE KIDS WITH
NEUROMUSCULAR HIGHOPATHY, IF
THEY WERE TO USE THE DEVICE
AND WOULD THERE BE
EXHAUSTION OF THE TONGUE AND
THEN A POINT OF SWITCHING
AND THAT IS A SITUATION
WHERE CLINICAL WORK AND
SCIENCE HAVE TO BENEFIT AND
BE INTUITIVE BUT BE SAFE SO
IF THERE IS A PHASE CALL
THERAPY INTERVENTION, FOR IT
TO ONLY BE ON DURING CERTAIN
PERIODS OF DAY MAY BE A
STRENGTH.
>> SO WE HAVE A COMMENT THAT
ALLUDES TO A RECOMMENDATION
AND OF COURSE YOU CAN'T
OFFER DIRECT MEDICAL ADVICE
TO ANYONE HERE BUT WE HAVE A
PARTICIPANT WHO HAS A
2-YEAR-OLD DAUGHTER WITH
APNEA, SHE UNDERWENT THE
SURGERY WITH LINGUOALAYSIA
BUT STILL PERSISTS, YOU HAVE
ANY RECOMMENDATIONS FOR THE
FAMILY?
>> JUST HAVE A GOOD
RELATIONSHIP WITH YOUR
HEALTHCARE PROVIDERS AND A
SOLID RELATIONSHIP WITH
THEM.
IF THEY HAVE EXPERIENCE WITH
THAT, THEY WILL AND IF THEY
CAN'T, MOST HEALTHCARE
PROVIDERS WILL PWOUBS THAT
OUT TO -- BOUNCE THAT OUT
TO OTHERS WHO HAVE MORE
EXPERIENCE SO MAKE SURE YOU
HAVE A GOOD SOLID HEALTHCARE
PROVIDER.
>> AND THIS SHOULD BE A
SHORT ONE, A QUESTION ABOUT
THE AGE OF THE OLDEST
PARTICIPANT IN THE CHILD
THAT YOU HAVE STUDIED.
>> WELL, 21, YOU CAN'T GO
-- I MEAN I HAVE IMPLANTED
OLDER BUT NOT FOR THE TRIAL
AND IT IS LIKE A RACE
AGAINST TIME IN YOUR 20s,
21, WE HAVE TO GET THE SLEEP
DECIDED AS AN ISSUE.
SO AGAIN IT GETS TO THE
POINT OF INCLUSION.
STUDIES ARE -- AND I AM
REALLY DEEPLY GRATEFUL TO
THE NIH FOR THIS OPPORTUNITY
HERE TO TALK TO PEOPLE BUT
TO ALSO WORK TOGETHER TO
MAKE SURE WE'RE DEVELOPING
GOOD, SAFE AND SOLID
RESEARCH BUT THERE ARE
QUESTIONS ABOUT INCLUSION
CRITERIA THAT ARE MEANT TO
BE SAFE AND GROUNDED IN
SCIENCE BUT LIKE EVERYTHING
ELSE, YOU KNOW, THEY HAVE
THEIR LIMITATIONS, RIGHT IN
TERMS OF WE START THE
STUDIES AND SAY I WISH I
COULD HAVE CHANGED THAT BY
SIX MONTHS OR THREE MONTHS
BUT 21 IS AS OLD AS WE GO
FOR THE STUDY.
>> AND A REQUEST --
>> GO AHEAD, ERIKA.
>> QUESTION FOR MS. TKPHUPBG
DOMINGUEZ.
BASED ON YOUR EXPERIENCE
WORKING WITH Dr. HARTNICK,
WOULD YOU BE WILLING TO
PARTICIPATE IN THE FUTURE IN
CLINICAL RESEARCH OR
CLINICAL STUDIES?
>> ABSOLUTELY, YES.
>> WHAT THEY WANT TO HEAR.
AND THE SIMPLE ANSWER TOO,
RIGHT, TO PINPOINT.
>> YES.
>> AND COULD YOU TELL US A
LITTLE BIT MORE?
I KNOW YOU MENTIONED A
LITTLE BIT THAT THE TEAM HAS
BEEN WILLING TO WORK WITH
YOU AND TAKE CARE OF YOUR
NEEDS AND I DON'T -- AND
YOUR SON'S NEEDS AND IT IS A
TEAM EFFORT, RIGHT, BUT IF
THERE ARE OTHER THINGS YOU
WOULD LIKE TO ADD TO?
>> FOR Dr. HARTNICK, IT
IS IMPORTANT FOR ME AS A
MOTHER THAT THE DOCTOR HAS
MY SON'S BEST INTEREST AND
THEY ARE EXCITED THAT
SOMETHING IS WORKING AND NOT
JUST LIKE OKAY, HAVE A GOOD
DAY, CHECK.
[LAUGHTER]
BUT SEEING HIS EXCITEMENT
WHEN THE THING WAS TURNING
ON AND HE IS LIKE OH IT IS
GOING TO BE WORKING,
KNOWING, FINDING OUT AFTER
THE SLEEP STUDY THAT HE
DOESN'T HAVE SLEEP APNEA
WHEN THE MACHINE IS ON AND
JUST HEARING HIS EXCITEMENT,
ALMOST AS EXCITED AS ME, I
AM LIKE OKAY, THANKS.
AND SO I JUST THINK THAT IS
AN IMPORTANT POINT, THAT THE
PATIENTS MATTER OVERALL,
RIGHT?
THAT THAT'S THE GOAL, RIGHT,
CREATING THINGS THAT HELP
PEOPLE'S HEALTH IS THE GOAL
AND IF YOU ARE HAVING THAT
VISION AND DOING SOMETHING
FOR IT, THAT THAT STAYS THE
FOCUS BECAUSE PEOPLE CAN DO
THINGS FOR DIFFERENT REASONS
AND LIKE WHEN SOMEONE IS
DOING IT MORE FOR THEIR EGO.
AND NOT THAT HE DOES THAT
BECAUSE HE PROBABLY GOES
HOME AND --
[INDISCERNIBLE]
>> OUR KIDS WOULD STAND UP
STRAIGHT IF I DID THAT.
[LAUGHTER]
>> BUT I AM GRATEFUL JUST
TO HAVE THAT TYPE OF
EXPERIENCE WHERE I LOVE --
THE LOVE IS FELT.
>> GO AHEAD, LAURIE.
>> I WAS GOING TO LEAVE THAT
FOR Dr. HARTNICK, MAYBE
YOU COULD TALK ABOUT HOW
REALLY THE RESEARCH IS
COLLABORATIVE, A PARTNERSHIP
WITH PARTICIPANTS AND HOW
IMPORTANT IT IS THAT THE
STUDY WORK WELL FOR
EVERYBODY.
>> YOU KNOW, STUDY WOULDN'T
HAPPEN IF YOU HAD ANSWERS.
STUDIES HAPPEN BECAUSE WE
REALLY WANT TO HELP CHILDREN
AND HELP PARENTS BUT TO TAKE
THIS DEVICE, WE WON'T KNOW
IF IT IS WORKING JUST
BECAUSE THE NUMBER GOES UP
AND DOWN.
WE WILL KNOW IT IS WORKING
IF PARENTS WHO KNOW THEIR
CHILDREN BEST NIGHT IN AND
NIGHT OUT, WILL SAY HIGH
CHILD, IT IS HELPING OR THEY
ARE MORE IN PAIN, YOU KNOW
THIS IS NOT A CHECK-IN AT
THE 1, 3, 6 AND 12-MONTH,
YOU HAVE TO WORK TOGETHER
AND PARENTS HAVE TO BE ABLE
TO FEEL THEY CAN REACH OUT
AT ANY POINT AND SAY I AM
HAVING TROUBLE WITH THIS OR
I DON'T UNDERSTAND THIS AND
THAT IT IS A OUT AND OUT --
I MEAN CLINICAL TRIALS ARE
SHARED TRIALS AND I ACTUALLY
THINK THAT IS TRUE ABOUT
CLINICAL CARE FOR CHILDREN
AND MAYBE THAT IS MY
PEDIATRIC BIAS.
CONTRIBUTE FOR EVERYBODY BUT
MORE SO FOR MY BIAS FOR
CHILDREN BUT I THINK WE'RE
LEARNING TOGETHER.
>> MS. DOMINGUEZ YOU HAVE
HIGHLIGHTED A NUMBER OF YOUR
MOTIVATIONS FOR
PARTICIPATION, INCLUDING
KNOWING THAT NICHOLAS' CARE
WAS A PRIORITY BUT ALSO THIS
SENSE YOU HAVE HAD ALL ALONG
OF CONTRIBUTING TO THE
GREATER GOOD.
CAN YOU TELL US A LITTLE BIT
ABOUT NICHOLAS' MOTIVATION
FOR WANTING TO PARTICIPATE
IN THE STUDY AND WHETHER OR
NOT HE HAD ANY TROPICAL
SYSTEM TREPIDATION OR
FEARS?
>> I AM NOT SURE OF
NICHOLAS' AWARENESS OF
CERTAIN THINGS BUT I DO TELL
HIM HE IS GOING TO BE
THROUGH SURGERY AND
SOMETHING IS GOING TO HURT,
YOU KNOW LIKE THINGS ARE
GOING TO HURT.
HE IS PRETTY OPEN.
YOU KNOW WHEN YOU GO INTO
SURGERY, HE IS SUPER-RELAXED
AND I AM LIKE OKAY YOU FEEL
GOOD, WHEN YOU COME OUT YOU
ARE NOT GOING TO FEEL THAT
GOOD, YOU MIGHT BE IN SOME
PAIN BUT HE LIVES IN THE
MOMENT AND THAT IS ONE OF
THE THINGS I LOVE ABOUT MY
SON, ALTHOUGH THERE ARE MANY
THINGS BUT HE IS MY BUDDHA.
I LOVE BUDDHA, HAVE MANY
BUDDHAS BUT HE IS MY BUDDHA,
HE LIVES IN THE MOMENT.
AND I HAVE GOT TEN SOMETHING
WRONG, LIKE MY SON IS THE
WHOLE GOAL.
PEOPLE WANT TO BE WHERE MY
SON IS.
HE IS JUST LIVING IN THE
MOMENT, LIKE I AM NOT
BOTHERED RIGHT NOW.
MAYBE I WILL BE BOTHERED
LATER BUT RIGHT NOW I AM
CHILLING.
SO YEAH, THAT'S MY SON.
>> WE WOULD INVITE ANYONE
WITH ADDITIONAL QUESTIONS TO
PLACE THEM IN THE Q & -- OH,
WE HAVE A COUPLE MORE.
>> I CAN TAKE THE FIRST ONE.
SO THIS LOOKS LIKE IT IS FOR
Dr. HARTNICK.
AT WHAT POINT IN THE CHILD'S
SLEEP APNEA CONSIDER THE
HYPOGLOSSAL SURGERY,
BASICALLY BEFORE ALL THE
OTHER SURGERY OPTIONS OR
AFTER?
>> RIGHT, I GUESS I AM GOING
TO PUT FORTH -- SONG IN
SCIENCE YOU ALWAYS WANT TO
PUT FORTH YOUR BIAS AND
SINCE I AM THE PERSON WHO
DROPPED THE IMP PLANTATION
AND I KNOW IT WORKS IN
CHILDREN AND ADULTS, PART OF
ME WOULD SAY IF YOUR CHILD
STILL HAS AN ISSUE AFTER
DOING THE SURGERIES, IT IS
SO EFFECTIVE.
ON THE OTHER HAND, IT IS A
NEW DEVICE AND IT DEPENDS ON
YOUR PARTICULAR THRESHOLD OF
BEING PART OF THE PROJECT
TOGETHER.
AND, YOU KNOW, IF CPA P
WORKS WELL AND THE MASK
WORKS WELL AND THINGS ARE --
IF YOUR HEART SAYS I AM NOT
READY TO BE PART OF THE
STUDY, YOU SHOULD EXPLORE
ALL OF THOSE DIFFERENT
OPTIONS.
BUT AT LEAST GETTIC THE
INFORMATION SO YOU CAN
INFORM YOURSELF KNOWING IT
IS AN OPTION, PROBABLY
EARLIER THAN SOME ARE AWARE
IT COULD BE AN OPTION.
I THINK ALL INFORMATION IS A
GOOD THING.
>> ARE YOU AWARE OF ANY
OTHER STUDIES THAT ARE
ONGOING LOOKING AT OUTCOMES
RELATED TO SPEECH WITH THIS
DEVICE OR THIS CONSPIRED
DEVICE?
>> NOT TO THE LEVEL OF
ACADEMIC RIGOR THAT THIS
STUDY IS DESIGNED FOR
BECAUSE I THINK THE QUESTION
WITH STUDIES IS TO BE ABLE
TO ENSURE HOW DO YOU
DISCRIMINATE ON THE BASELINE
OF CHANGE AND HOW YOU CAN
ACTUALLY -- THERE CAN BE A
RECALL BIAS WHERE SOMEONE
COULD SAY I THINK MY CHILD
DOES BETTER.
SO THIS IS ONE OF THE
REASONS WE HAVE SPENT AN
ENORMOUS AMOUNT OF TIME
WORKING WITH THE NIH AND
OTHERS IN THE STUDY THAT WE
FEEL LIKE WE CAN STAND BY --
AND BY THE WAY, I DON'T KNOW
YET THAT IT WORKS, I HOPE IT
WORKS AND IF IT WEREN'T FOR
PEOPLE LIKE YOU, WE WOULDN'T
BE DOING THE STUDY BUT I
THINK IT IS IMPORTANT TO
KNOW AND IMPORTANT TO ASK
THE QUESTION WELL.
>> CAN I SAY SOMETHING REAL
QUICK?
SO AS FAR AS LIKE HAVING SO
MANY DIFFERENT SURGERIES,
BECAUSE MY SON HAD SO MANY,
I WOULD HEAR THE SURGEON
ALWAYS SAYING, YOU KNOW, BUT
HE IS STILL GOING TO NEED
THE MACHINE, I THINK IT IS
CALLED THE CPA P MACHINE.
HE WOULD STILL -- NO MATTER
ANY OF THESE SURGERIES, HE
WAS GOING TO NEED THIS
MACHINE WHICH MY SON DID NOT
TOLERATE.
HE DID NOT TOLERATE THE
MACHINE.
AND FOR ME ALTHOUGH THIS
SURGERY REQUIRED HIM TO HAVE
TWO INCISIONS THAT FOR ME
WERE HARD TO SEE BECAUSE
THAT'S MY BABY AND LIKE YOU
ARE CUTTING INTO MY SON, BUT
THERE IS NO MACHINE AND I
NOW DON'T HEAR THIS GURGLING
SOUND SOMETIMES I WOULD HEAR
WHEN HE WAS SLEEPING, LIKE
HIS TONGUE WAS CLAPSED, LIKE
I DON'T EXPERIENCE THAT
ANYMORE.
AND FOR ME, IF IT MEANS HE
IS GOING TO SLEEP MORE
COMFORTABLY, IT IS GOING TO
IMPROVE HIS BREATHING WHILE
HE SLEEPS, THE INCISIONS ARE
WORTH IT.
SO I JUST WANT TO MENTION
THAT.
>> NO, I THINK THAT IS
IMPORTANT, THE OUTCOME IS
BETTER THAN THE POTENTIAL --
[INAUDIBLE].
SO I KNOW WE MAY HAVE A FEW
MORE MINUTES --
>> YES, ANOTHER QUESTION
ACTUALLY ON THIS.
>> JUST BEFORE.
>> YES, JUST CAME IN.
[LAUGHTER]
AND THIS ONE IS ACTUALLY FOR
MS. DOMINGUEZ, DO YOU KNOW
IF INSURANCE COVERS THE
PROCEDURE?
>> FOR --
>> THE SIMILARITY, YES.
>> FOR US, YES, IT DID, SO I
AM SUPER GRATEFUL.
WE HAD BLUE CROSS BLUE
SHIELD AND THEN ANOTHER
HEALTH INSURANCE THAT COVERS
ANYTHING BLUE CROSS BLUE
SHIELD DOESN'T.
I DON'T KNOW IF OTHER
INSURANCE MIGHT NOT --
>> SOMETIMES IT IS VERY
STRAIGHTFORWARD AND EASY AND
SOMETIMES IT IS REALLY
PAINFUL AND TAKES A WHILE.
SO IT CAN BE THE MOST
FRUSTRATING PART OF THIS AND
OFTEN I HAVE TO WRITE A LOT
OF LETTERS FOR A LOT OF
DENIALS AND SOME PARENTS
JUST HAVE TO BREATHE WHILE
THEIR CHILD IS SUFFERING AND
CAN BE QUITE A EXPERIENCE.
BUT IT WORKS WELL AND I HAVE
HAD A COUPLE OF KIDS WHO
COULD NOT GET APPROVED SO IT
IS A RARITY BUT IT IS
REALITY.
>> THAT WAS BE AN IMPORTANT
QUESTION TO ASK FOR PARENTS
COMING IN, THAT THAT IS ONE
HURDLE THEY MAY OR MAY NOT
HAVE TO FACE.
ARE THERE OTHER THINGS,
MS. DOMINGUEZ, OF LESSONS
LEARNED ALONG THE WAY OR
THINGS YOU SHOULD BE
THINKING ABOUT, EITHER FROM
YOUR SIDE OR Dr. HARTNICK,
AS YOU CONSIDER THIS AND
TAKE INTO CONSIDERATION THE
OPTIONS?
>> WHAT I SAID ABOUT HIM
HAVING SO MANY SURGERIES,
LIKE I AM NOT TELLING NUN
ANYONE NOT TO GET THE
REDUCTION BUT IT WAS
TRAUMATIC.
MY SON HAD SOME BLEEDING AND
THEY DIDN'T KNOW WHAT WAS
HAPPENING, IT WAS IN HIS
MOUTH AND HE WAS SWALLOWING
THE BLOOD AND ENDED UP
THROWING UP THE BLOOD CLOTS
AND I AM STILL TRAUMATIZED.
WHEN HE COUGHS, HE THINKS HE
WILL SPIT OUT BLOOD TO THIS
DAY AND IT MAY NOT BE
EVERYONE'S EXPERIENCE BUT IF
I HAD KNOWN ABOUT SOMETHING
LIKE THIS, I WOULD HAVE WENT
DIRECTLY TO IT RATHER THAN
HAVING HIM GO THROUGH
APPROXIMATELY UNNECESSARY
TRAUMA.
ALTHOUGH HE WENT THROUGH IT
AND EVERYTHING IS MEANT TO
BE WHAT IT IS, IT IS DONE,
RIGHT, BUT IF I HAD A CHOICE
TO REDO IT AND HEAR ABOUT
THIS, I WOULD SAY YOU KNOW
WHAT, LET'S DO THIS AND WE
DON'T HAVE TO DO THAT, THEN
I WOULD BE LIKE OKAY.
YEAH.
>> I WOULD JUST SAY IN TERMS
OF A POINT OF VIEW FOR
PARENTS, THIS IS A DEVICE IF
DONE WELL IS SAFE AND THE
PARENTS AND KIDS TOLERATE IT
WELL.
BUT I THINK IF YOU THINK OF
IT AS YOU ARE GOING TO GO
THROUGH THE SURGERY AND IT
IS DONE, THAT IS IT, IT IS A
YEAR EXPERIENCE, A SHARED
EXPERIENCE TOGETHER AND I
THINK IT IS SUPER IMPORTANT
THROUGHOUT ALL OF THIS, IT
IS THAT NETWORKS SUSPECT AND
NOT JUST A YEAR BUT IT WILL
TAKE TENDING AFTERWARDS.
BUT IT IS IMPORTANT TO KNOW
IT IS A RELATIONSHIP.
>> AND EVEN JUST THINKING
ABOUT THE CPA P MACHINE,
LIKE OH MY GOD, LITERALLY I
WAS TOLD BECAUSE OF MY SON'S
OBSTRUCTION, THE CPA P
MACHINE HAD TO BE ALL THE
WAY UP AND I WAS TOLD BY THE
SURGEON, NOT Dr. HARTNICK
BUT ANOTHER SURGEON, HAVING
IT ALL THE WAY HIGH IS THE
EQUIVALENT OF BEING ON THE
HIGHWAY DRIVING AND HAVING
MY SON'S FACE OUT OF THE
WINDOW LIKE TYPE OF SPEED
AND I WAS LIKE WHAT?
THAT SOUNDS CRAZY.
SO WHEN NICHOLAS WAS HAVING
IT AT NIGHT HE WASN'T
TOLERATING IT AND I PUT THIS
ON AND FELT LIKE I WAS
SUFFOCATING SO I WAS LIKE
NO, WE WILL LOOK FOR ANOTHER
SOLUTION.
AND I AM GREATFUL HE HAD
ONE.
>> NO, I AGREE, I THINK IT
IS A WONDERFUL OPPORTUNITY
TO BE ABLE TO BE PART OF
Dr. HARTNICK'S STUDY.
GLAD YOU FOUND OUT ABOUT IT,
YOU KNOW, AS WELL, BUT DOING
BETTER NOT ONLY FOR
NICHOLAS' WELL-BEING BUT
DOING BETTER IN SCHOOL AND
YOU ARE AN ADVOCATE AS WELL,
NOT ONLY FOR NICHOLAS BUT
ALSO FOR THIS STUDY.
AND I KNOW WE'RE GETTING
CLOSE TO TIME SO I DO WANT
TO JUST TAKE THE TIME TO
MAKE SURE WE DON'T RUN UP TO
THE LAST MINUTE BEFORE WE
HAVE AN OPPORTUNITY TO SAY
THANK YOU.
AND THERE WAS SOMETHING THAT
CAME CAME IN.
>> YEAH, PLEASE.
>> THE AUDIENCE HAS TO SAY
AND I THINK THEY ECHO WHAT
WE FEEL AS WELL, THAT YOU
ARE AN INSPIRING MOTHER AND
REALLY TAKING CARE OF
EVERYTHING, HAVE WRITTEN THE
BOOK, YOU HAVE SUCH CALM AND
POISE, EVEN IN THE MIDST OF
THINGS THAT MAYBE OTHERS
WOULD FACE AND PROBABLY BE
BROKEN.
SO WE APPLAUD YOU FOR ALL
THAT YOU DO AND THANK YOU
FOR CONTINUING TO INSPIRE
ALL OF US AND VALIDATE THE
WORK THAT WE DO HERE AT NIH
AND AS PART OF THE INCLUDE
PROGRAM AND REALLY
SUPPORTING Dr. HARTNICK
AND HIS RESEARCH.
BECAUSE AS YOU MENTIONED,
THIS ISN'T POSSIBLE
WITHOUT -- [INAUDIBLE].
THEY CREATE THE SCIENCE BUT
IF THERE IS NO
PARTICIPATION, THE STUDY
WOULDN'T BE THERE.
SO Dr. HARTNICK, THANK YOU
FOR THE RESEARCH YOU ARE
DOING, IT IS SUCH AN
IMPORTANT TOPIC AND
HOPEFULLY WILL PUSH FORWARD
FOR THE FDA APPROVAL OF
OTHER DEVICES AND AS WE LOOK
AT OTHER POPULATIONS AS
WELL.
SO THANK YOU FOR ALL OF THE
WORK YOU ARE DOING.
I WILL TURN IT OVER TO
MS. DOMINGUEZ TO SEE IF YOU
HAVE ANY LAST WORDS OR
ANYTHING YOU WOULD LIKE TO
SHARE WITH THE AUDIENCE?
>> WELL I AM SO GRATEFUL,
HEARING YOU SAY THOSE WORDS
MEANS A LOT TO ME BECAUSE MY
MISSION IN THE WORLD IS TO
BREAK BARRIERS AROUND PER
CEPTION AND TO BE IN LOVE
BECAUSE THAT IS WHERE WE ARE
MEANT TO BE.
AND I LOVE THAT MY SON
AWAKENS ME TO THAT
OPPORTUNITY.
AND SOME PEOPLE THINK I SAY
THAT BECAUSE MY SON WAS BORN
WITH DOWN SYNDROME BUT
REALLY IT IS BECAUSE I LOVED
HIM BEFORE I HEAD MINIMUM.
I LOVED HIM BEFORE I SAW
HIM.
AND I AM NOT GOING TO CRY.
[LAUGHTER]
WAIT A MINUTE, THE TEARS ARE
EMERGING, THEY ARE RIGHT AT
THE TIP OF MY EYELIDS.
>> JUST SO YOU KNOW YOU ARE
NOT ALONE, MINE ARE HERE
TOO.
>> BUT TO REALLY GET TO
EXPERIENCE WHAT
UNCONDITIONAL LOVE IS AND TO
HAVE EXPERIENCE IN MY
LIFETIME WHAT UNCONDITIONAL
LOVE ISN'T PROVIDED ME ALSO
THE TOOLS TO BE WHAT I
NEEDED TO BE FOR MYSELF AND
MY SON NOW WHICH, YOU KNOW,
THAT IS WHY FOR ME, SOME OF
IT, DID I PASS ALL OF THOSE
EXPERIENCES TO BE WHO I AM,
BECAUSE COULDN'T THERE HAVE
BEEN AN EASY BUTTON?
BUT I ALSO WANT TO MENTION
THE AWAKEN WINNERS, I WILL
SHARE, IT IS ON AMAZON BUT
ALSO AT THE AWAKENED
WINNERS.COM AND IF YOU BUY
ONE THROUGH THE
AWAKENEDWINNERS.COM, I WILL
SEND YOU A COPY MYSELF.
I ALSO HAVE A COUPLE OF
SONGS ON YOUTUBE, ONE OF
THEM IS CALLED ALDERMEN AND
ONE OF THEM IS CALLED I
ALREADY WON, BOTH SONGS HAVE
MY SON IN THEM AND THE ONE
THAT IS CALLED DOWN
SYNDROME, I AM THINKING
DON'T YOU KNOW I ALREADY
WON, I RAP DOWN SYNDROME TO
21 AND MY SON SAYING DON'T
YOU KNOW I ALREADY WON, I
ROCK DOWN SYNDROME TILL 21
AND IT IS A REALLY GREAT
VIDEO IF YOU WANT TO CHECK
IT OUT.
WE ARE WORKING ON NEW MUSIC
AND MY VISION IS TO KEEP
SPREADING LOVE AND I
DIGRESS, THANK YOU FOR
HAVING ME HERE AND MUCH WILL
HAVE TO ALL OF YOU AND THANK
YOU FOR WHAT YOU ARE DOING.
>> THANK YOU, TRULY
APPRECIATE IT AND I
DEFINITELY WILL BE CHECKING
OUT THE MUSIC BECAUSE I LOVE
THAT AND Dr. HARTNICK WE
WILL GIVE YOU A CHANCE TO
GIVE A FINAL COMMENT AS
WELL.
>> THANKS TO THE TEAM AND I
WILL SAY I HAVE THOSE SONGS
AND I LOVE THEM, AND
LISTENING TO THOSE SONGS IT
IS INCREDIBLE SO THANKS,
EVERYBODY.
>> THANK YOU, AND Dr.
RYAN, YOU HAVE THE LAST
COMMENT?
THANK YOU AGAIN FOR JOINING
US IN THIS WEBINAR.
IT WAS RECORDED AND BE
AVAILABLE ON THE NIH
VIDEOCAST AND WE WILL SEND
AROUND A LINK FOR ALL OF
THOSE ABLE TO JOIN US FOR
THE WEBINAR.
AND Dr. HARTNICK IF YOU
DON'T MIND WE WILL SHARE
YOUR E-MAIL ADDRESS SO THAT
THOSE INTERESTED WILL REACH
OUT TO YOU AS WELL.
SO Dr. RYAN?
>> I WILL JUST ECHO WHAT
YOU SAID ERIKA, THANKS FOR A
REALLY WONDERFUL AND
INSPIRING WEBINAR AND JUST
CAN'T THANK YOU ENOUGH.
>> GRATEFUL FOR YOU ALL,
THANK YOU FOR WILL THING ME
PARTICIPATE.
>> THANK YOU ALL VERY, VERY
MUCH.
>> YOU TOO, HAVE A
WONDERFUL REST OF THE DAY.
BYE.
[ END OF SESSION ]