NCT02907398

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (actual)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This registry is a multi-center, prospective, observational registry, conducted in the United States and Europe. Some data may be collected retrospectively in patients currently implanted (implanted prior to enrollment) through the 12-month follow-up time frame. The CE-marked and FDA-approved Inspire system will be used within its intended use, allowing for of use of any future approved system component models. This protocol does not include any additional stressful or invasive tests, which are not a part of standard of care.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inspire therapy
OTHER	No intervention

Timeline

• Start date: 2016-10-19
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2016-09-20
• Last updated: 2025-06-19

Locations

64 sites across 5 countries: United States, Belgium, Germany, Netherlands, Switzerland