Status:
COMPLETED
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
22+ years
Phase:
PHASE3
Brief Summary
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 obs...
Detailed Description
The STAR trial is a multicenter, prospective trial that includes a randomized controlled therapy withdrawal study. The primary and secondary endpoint data were collected during an in-laboratory sleep ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
929 Patients enrolled
Trial Details
Trial ID
NCT01161420
Start Date
July 1 2010
End Date
April 1 2017
Last Update
August 25 2017
Active Locations (22)
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1
California Sleep Institute
Palo Alto, California, United States, 94303
2
Clinical Research Group of St. Petersburg, Inc.
St. Petersburg, Florida, United States, 33707
3
University of South Florida
Tampa, Florida, United States, 33606
4
Advanced ENT
Atlanta, Georgia, United States, 30342