Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Active, not recruiting
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT02907398
- Lead Sponsor
- Inspire Medical Systems, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 5000
Inclusion Criteria
Inclusion Criteria:<br><br>Any patient implanted with or receiving an Inspire implant, who meets the following<br>criteria, is eligible to participate in the registry:<br><br> 1. Capable of giving informed consent, as required per institution<br><br> 2. Willing to return for routine clinic visits as required for Inspire therapy<br> management<br><br>Exclusion Criteria:<br><br>Any patient who meets any of the following criteria will not be eligible to participate<br>in the registry<br><br> 1. Has a life expectancy of less than 1 year<br><br> 2. Any reason the clinician deems patient is unfit for participation in the study
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Apnea Hypopnea (AHI) from Baseline to 12-Months;Change in Epworth Sleepiness Scale (ESS) from Baseline to 12 Months
- Secondary Outcome Measures
Name Time Method Patient Experience with Therapy (PET);Therapy Adherence;Advance or Additional Titrations;Physical Assessment;Clinical Global Impression (CGI-I);Device Data Collection;Insomnia Severity Index (ISI)