Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study

Status Completed

Clinical Trial Summary

The purpose of this study is to obtain additional safety and efficacy data on the use of Inspire® therapy for the treatment of subjects with moderate to severe Obstructive Sleep Apnea.

Clinical Trial Description

This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. Each subject will serve as their own control.

The study will collect pre-operative two-night home sleep testing, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected. Therapy usage and device adjustment data, as well as a subject satisfaction with therapy survey, will be collected for additional analysis.

Post-implant, procedure- and device-related events, QoL questionnaires, therapy usage and device adjustment data will be collected. Sleep study data will collected during the 2-month visit and, if conducted, a 3-month visit using a single night in-lab titration PSGs At 6 and 12 months post-implant, 2-night home sleep testing will be completed. Safety data will be collected throughout the study. Subjects will be exited from the study following the 12-month visits.

The subject population will consist of otherwise healthy men and women that are at least 21 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with study requirements for the specified follow-up duration, 3) Met all inclusion and exclusion criteria of this protocol.

Up to 60 subjects will be implanted at up to 5 sites in Germany. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02293746
Study type	Interventional
Source	Inspire Medical Systems, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	June 2014
Completion date	January 9, 2017

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