Status:
COMPLETED
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Lead Sponsor:
Apnex Medical, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway ...
Eligibility Criteria
Inclusion
- Eligibility Criteria
- Previously diagnosed with moderate-to-severe obstructive sleep apnea.
- Subject has failed or does not tolerate CPAP treatment.
- Age between 21 and 70 years.
- Body mass index (BMI) less than or equal to 37.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01211444
Start Date
July 1 2010
End Date
August 1 2013
Last Update
April 15 2015
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Saint Vincent Hospital
Indianapolis, Indiana, United States, 46260
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Clinilabs, Inc.
New York, New York, United States, 10019