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Frequently asked questions about our Research Study of Tongue Pace Maker System (The Hypoglossal Nerve Stimulator) in children ages 10 to 21 with Down Syndrome and Severe Obstructive Sleep Apnea
Children with Down syndrome, ages 10-21, who have had a adenoidectomy and tonsillectomy but who still have severe sleep apnea and who cannot tolerate CPAP therapy.
Children who are obese to the point where they may not benefit from the stimulator or children with extremely severe sleep apnea which is beyond what the device so far seems to be able to help.
We are also excluding children who require MRI or have active cardiac disease or swallowing issues.
Yes, you can participate, and we will help as much as we can on a case by case basis. There are 4 other centers who are also enrolling children into this study which may be more helpful to some:
University Hospitals Rainbow Babies and Children’s Hospital (Cleveland, OH)
Children’s Hospital of Pittsburgh (Pittsburgh, PA)
Henrietta Egleston Hospital for Children (Atlanta, GA)
Cincinnati Children’s Hospital (Cincinnati, OH)
If you or someone you know is interested in participating at these centers, please contact Vanessa De Guzman (firstname.lastname@example.org) or Dr. Christopher Hartnick (Christopher_hartnick@meei.harvard.edu) and they will provide you with further details.
No, you will not be compensated for participating in this study.
If you are interested in your child being part of this study, please contact Vanessa de Guzman (email@example.com) or Dr. Hartnick (firstname.lastname@example.org).
Pre-op evaluation includes a sleep study within the past 6 months and a procedure called a sedated sleep endoscopy which allows us to mimic sleep and to predict if the stimulator will help your child. After the procedure (which generally takes around 3 hours), your child will also need a sleep study and attend an office visit 1 month, 1 month + 1 week, 2 months, 6 months, and 1 year after surgery.
Absolutely. Please contact Vanessa de Guzman (email@example.com) and she can help to arrange this.
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