Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
NCT02907398 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000
Last updated 2025-06-19
Summary
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis.
In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.
Conditions
Interventions
- DEVICE
-
Inspire therapy
- OTHER
-
No intervention
Sponsors & Collaborators
-
Inspire Medical Systems, Inc.
lead INDUSTRY
Principal Investigators
-
Gwen Gimmestad · Inspire Medical Systems, Inc.
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-19
- Primary Completion
- 2025-09-30
- Completion
- 2025-12-31
Countries
- United States
- Belgium
- Germany
- Netherlands
- Switzerland
Study Locations
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