Status:
TERMINATED
Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
Lead Sponsor:
Apnex Medical, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option fo...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age 21 to 80 years
- Body mass index (BMI) ≤ 35 kg/m²
- Previously diagnosed with Moderate to severe OSA
- Individual has failed or does not tolerate PAP therapy
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01446601
Start Date
August 1 2011
End Date
August 1 2013
Last Update
April 15 2015
Active Locations (14)
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1
MidAmerica Neuroscience Research Institute
Lenexa, Kansas, United States, 66214
2
Veritas Clinical Specialties
Topeka, Kansas, United States, 66606
3
Kentucky Research Group
Louisville, Kentucky, United States, 40217
4
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815