NCT04801771

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System.

Detailed description

This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome, moderate to severe sleep apnea, and post-adenotonsillectomy, for 12 months after undergoing implant of the Inspire Upper Airway Stimulation (UAS) System. The study is being conducted in order to evaluate objective change in cognition and expressive language after implant and therapy with the Inspire UAS System. Prior to implant subjects will be required to meet eligibility criteria, complete quality of life questionnaires and undergo neurocognitive testing (NCT) and expressive language sampling. Eligibility criteria will be determined via review of medical records, an in-lab polysomnography (sleep study), and a drug-induced sleep endoscopy (DISE). After implant of the Inspire UAS System, subjects will undergo five (5) study visits. Four (4) of the visits will include an in-lab sleep study (PSG). Follow-up expressive language sampling and neurocognitive testing will be performed at 6 months post-implant. Follow-up quality of life questionnaires will be completed at 12 months post-implant. Subjects will conclude their participation in the study at the end of their 12 month study visit.

Conditions

• Down Syndrome
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inspire Upper Airway Stimulation (UAS) System	The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.

Timeline

• Start date: 2021-06-24
• Primary completion: 2027-02-28
• Completion: 2027-09-30
• First posted: 2021-03-17
• Last updated: 2025-09-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study