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

Obstructive Sleep Apnea Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

• NCT number: NCT02907398
• Study type: Observational [Patient Registry]
• Source: Inspire Medical Systems, Inc.
• Status: Active, not recruiting
• Start date: October 19, 2016
• Completion date: December 2025