Inspire PAS

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

Inspire PAS [NCT02413970]

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

Device: Inspire® UAS System

Primary Investigator: Hellmann

Drug/Device Information
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of Inspire therapy
The Inspire system was developed for moderate to severe OSA in patients who are not effectively treated by CPAP
Inspire II Upper Airway Stimulator, Model 3024 (Implantable Pulse Generator, IPG)
Inspire Stimulation Lead, Model 4063 (stimulation lead) and the Inspire Sensing Lead, Model 4323 (sensing lead)
Post-market, non randomized
Inspire Medical Systems, Inc.
Major Inclusion and Exclusion
Moderate-to-severe OSA based on history and physical or have a diagnosis of OSA (20≤, AHI ≤ 65) based on a prior in-lab Polysomnography
Documentation the subject not effectively treated with CPAP therapy
Age 22 or above
No central + mixed apneas > 25% of the total apnea–hypopnea index (AHI)
No condition or procedure that has compromised neurological control of the upper airway
No implantable device that may be susceptible to unintended interaction with the Inspire system
No BMI of > 32