Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)

Completed · Phase 3

Conditions studied: Obstructive Sleep Apnea

In brief

The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by improving airway patency through stimulation of the hypoglossal nerve. Study objectives include demonstrating that the Inspire system improves key indices of sleep apnea in a pre-specified percentage of patients.

Key facts

Study ID

NCT01161420

Run by

Inspire Medical Systems, Inc.

People needed

929

Starts

2010-07-01

Expected to finish

2017-04-01

Last updated by the study team

2017-08-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Likely suffer moderate-to-severe OSA based on history and physical
• Have failed or have not tolerated CPAP treatment
• Willing and capable of providing informed consent
• Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
• Willing and capable to return for all follow-up visits and sleep studies, including the evaluation procedures and filling out the questionnaires

You may not qualify if…

• Body Mass Index limits
• Surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat
• Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Where it is running

• California Sleep Institute — Palo Alto, California, United States
• Clinical Research Group of St. Petersburg, Inc. — St. Petersburg, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Advanced ENT — Atlanta, Georgia, United States
• Wayne State University / Detroit Medical Center — Detroit, Michigan, United States
• Borgess Research Institute — Portage, Michigan, United States
• North Memorial Medical Center — Maple Grove, Minnesota, United States
• St. Cloud ENT — Saint Cloud, Minnesota, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University Hospitals / Case Western Reserve — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center; Montefiore — Oakland, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Sleep Medicine Associates of Texas — Dallas, Texas, United States
• Swedish Health Services — Seattle, Washington, United States
• Froedtert Memeorial Hospital — Milwaukee, Wisconsin, United States
• Deparment of Pulmonology Head and Neck Surgery, Universitair Ziekenhuis Antwerpen — Antwerp, Belgium
• Central Hospital University of Bordeaux — Bordeaux, France
• Hospital Foch — Paris, France
• Krankenhaus Bethanien Solingen — Solingen, DE, Germany
• St. Franziskus Hospital — Cologne, Germany
• Universitäts-HNO-Klinik Mannheim — Mannheim, Germany
• St. Lucas Andreas Ziekenhuis — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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