Inspire® Post-Approval Study / Protocol Number 2014-001

Obstructive Sleep Apnea Clinical Trial

Official title: Inspire® Upper Airway Stimulation System (UAS): Post-Approval Study Protocol Number 2014-001

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy.

Clinical Trial Description

This is a multi-center, prospective, single-arm study conducted under a common protocol. Each subject will serve as their own control. Each subject will be followed for 5 years from date of implant.

Potential study subjects will be considered for study participation and consented once pre-implant screening and implant qualification process have been completed. This includes an in-lab PSG, surgical consultation, and a drug-induced sleep endoscopy procedure.

This study will collect pre-operative baseline data including, verification of ineffective CPAP treatment, PSG information, medical history and subject quality of life measures. Intra- and post- operative procedure data will be collected.

Post-implant, procedure- and device-related adverse events, QoL questionnaires, Functional Tongue Exam, therapy usage and device adjustment data will be collected. In-lab PSG sleep study data will be collected during the 2-month and 1 & 3 year follow-up visits, home sleep tests will be conducted and data collected at the 6-month and 2, 4, & 5 year follow-up visits.

The subject population will consist of otherwise healthy men and women that are at least 22 years old and have: 1) Provided written informed consent to participate, 2) Indicated a willingness to comply with the study requirements for the specified follow-up duration, and 3) Met all inclusion and exclusion criteria of this protocol.

Up to 127 subjects will be implanted at a minimum of 10 and a maximum of 20 qualified sites in the United States. ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

• NCT number: NCT02413970
• Study type: Interventional
• Source: Inspire Medical Systems, Inc.
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Completion date: June 2025