NCT02413970

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Inspire® UAS System	This is a single-arm study; all participants will be implanted with the Inspire® UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.

Timeline

• Start date: 2015-05-01
• Primary completion: 2025-03-01
• Completion: 2025-06-01
• First posted: 2015-04-10
• Last updated: 2024-12-27

Locations

14 sites across 1 country: United States