Obstructive Sleep Apnea in Down Syndrome Patients, Treatment with Inspire® Implant – Pilot Study

Study to Evaluate the Safety and Efficacy of the Hypoglossal Nerve Stimulator in Adolescents and Young Adults with Down Syndrome and Obstructive Sleep Apnea

Protocol Description

Through this trial, researchers will study use of the Inspire® implanted nerve stimulation system in adolescents and young adults with Down syndrome and moderate to severe obstructive sleep apnea (OSA). This condition occurs when the airway is blocked during sleep, causing breathing difficulty. Mild electrical stimulation to the hypoglossal nerve, located under the chin, helps lift a sleeping patient’s tongue from the back of the throat, which can help to reopen the airway in some patients with OSA. Although OSA affects up to 1 percent of the general pediatric population, it is estimated that it affects 30 to 60 percent of people with Down syndrome.

Study Level: Pilot

Eligibility Criteria

Subject to exclusion criteria, the study is accepting individuals of both genders, ages 10 to 21 years, who have Down syndrome and for whom certain other treatments for OSA, including adenotonsillectomy have not worked.
Males and Females: Ages 10 to 21 years


Participants will have a baseline visit, which includes a physical, and additional visits for screening procedures, including an overnight sleep study and an endoscopy. Placement of the stimulator requires surgery and a hospital stay. Following the implant, patients will be seen at 1, 4 and 5 weeks, and 2, 6 and 12 months, with the device activated at the 4-week visit. Following the study period, patients will require annual follow up visits with the surgeon to make sure the device is functioning properly and surrounding tissue remains healthy.
Visits: At least 9
Duration: About 1 year

Status: Open to Enrollment

Source(s) of Support

Inspire Medical Systems

Primary Investigator

Allison Tobey, MD

Contact Information

For more information about the study or enrollment, please contact:
Amber Shaffer, PhD, Research Coordinator