Inspire Upper Airway Stimulation System for Obstructive Sleep Apnea in Young Adults
This study is looking at the Inspire Upper Airway Stimulation (UAS) System in young adults aged 18 to 21 who have moderate to severe obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. You might be able to join if other treatments like CPAP haven't worked or aren't suitable, and if you can't have or weren't helped by adenotonsillectomy surgery. The study will track how well the Inspire system works to improve your breathing during sleep (measured by Apnea Hypopnea Index or AHI) and any side effects over five years. The study plans to enroll 60 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will follow participants who receive the Inspire Upper Airway Stimulation System. It is a single-arm study, involving about 60 participants.
- What's involved
- You would have the Inspire Upper Airway Stimulation System implanted. Researchers will collect data at baseline, one month after implant activation, and then at 6 months, 1, 2, 3, 4, and 5 years after implant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for five years after the Inspire Upper Airway Stimulation System is implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pediatric Post-Approval Registry
At a glance
Conditions
Where it's being run
8 sites across 7 statesWho to contact
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What this trial measures
- Evaluation of device and/or procedure related adverse events over timeImplant through 5 years post-implant
relevant adverse events will be collected and reported
- Evaluation of the improvement of Apnea Hypopnea Index (AHI) over timethrough 5 years post-implant
Baseline (pre-implant) AHI compared to AHI after implant (collected and reported at annual study visits). The Apnea Hypopnea Index (AHI) is the number of apnea and hypopnea events per hour of sleep. A lower AHI indicates less severe sleep apnea.