Last updated on March 2019

Inspire Post-Approval Study / Protocol Number 2014-001

Brief description of study

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

Detailed Study 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. Intraand 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.

Clinical Study Identifier: NCT02413970

Contact Investigators or Research Sites near you

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Kirk Withrow, MD

The University of Alabama at Birmingham Medical Center
Birmingham, AL United States
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Eric Kezirian, MD

University of Southern California
Los Angeles, CA United States
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Tapan Padhya, MD

Tampa General Hospital
Tampa, FL United States
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Amy Geis

Emory University Hospital
Atlanta, GA United States
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Amy Geis

Kentucky Research Group
Louisville, KY United States
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Maria Suurna, MD

Weill Cornell Medicine
New York, NY United States
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Kingman Strohl, MD

University Hospitals
Cleveland, OH United States
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Douglas Trask, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Richard J Schwab, MD

University of Pennsylvania, Division of Sleep Medicine
Philadelphia, PA United States
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Maurtis Boone, MD

Thomas Jefferson University and Hospital
Philadelphia, PA United States
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Amy Geis

University of Pittsburgh Medical Center
Pittsburgh, PA United States
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Amy Geis

Medical University of South Carolina
Charleston, SC United States
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Jeremy Tabak, MD

South Miami Hospital
Miami, FL United States
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Joseph Hellman, MD

The Christ Hospital
Cincinnati, OH United States
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Recruitment Status: Open

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