Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study

Recruiting Observational Study
Obstructive Sleep Apnea (OSA)
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 and older
Sex
Any
Study type
Observational
Participants needed
70 (estimated)
Sponsor
Inspire Medical Systems, Inc. · Industry
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About This Trial

The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject is at least 18 years of age; 2. Subject has a diagnosis of severe OSA (65 ≤ AHI ≤ 100) based on a recent sleep study (within 12 months) OR Subject has a diagnosis of moderate to severe OSA (15≤AHI≤100) AND a baseline Body Mass Index of 32\<BMI≤40 kg/m2; 3. Subject has…
Contacts

Gwen Gimmestad

763-392-9966

gwengimmestad@inspiresleep.com

CONTACT