Pediatric Post-Approval Registry

Recruiting Observational Study
Obstructive Sleep Apnea
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 21
Sex
Any
Study type
Observational
Participants needed
60 (estimated)
Sponsor
Inspire Medical Systems, Inc. · Industry
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About This Trial

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject is between 18 and 21 years of age; 2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study; 3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;…
Contacts

Gwen Gimmestad

763-392-9966

gwengimmestad@inspiresleep.com

CONTACT

Mike Swierzewski, MS

michael.swierzewski@inspiresleep.com

CONTACT