Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
- Registration Number
- NCT01446601
- Lead Sponsor
- Apnex Medical, Inc.
- 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 for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 132
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) The Treatment Arm is implanted with the HGNS System and therapy is turned on at 1 month post-implant. Control Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical ) The Control Arm is implanted with the HGNS System and therapy is turned on at 7 months post-implant.
- Primary Outcome Measures
Name Time Method Safety Analysis 12 months Description of all adverse events
Reduction in OSA Severity from Baseline to 6 Months The proportion of subjects that experience clinically meaningful improvement in AH1 (reduction \>50% and AHI \<20) and ODI 4% (reduction \>= 25% or ODI 4% \<5)from Baseline to 6 Months will be significantly greater in the Treatment Group compared to the Control Group
Long-term Reduction in OSA Severity 12 months The proportion of subjects in the Treatment Group that experience clinically relevant improvement in AHI (reduction \>50% and AHI \<20) and ODI 4% (reduction \>=25% or ODI 4% \<5 at 12 months compared to Baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Community Research
🇺🇸Cincinnati, Ohio, United States
MidAmerica Neuroscience Research Institute
🇺🇸Lenexa, Kansas, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
The Center for Sleep and Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Clinilabs
🇺🇸New York, New York, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
St. Lukes Hospital
🇺🇸St. Louis, Missouri, United States
Sleep Med of South Carolina
🇺🇸Columbia, South Carolina, United States
Westmead Hospital
🇦🇺Sydney, New South Wales, Australia
Veritas Clinical Specialties
🇺🇸Topeka, Kansas, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Sleep Therapy and Research Center
🇺🇸San Antonio, Texas, United States
IBAS, The Austin Hospital
🇦🇺Melbourne, Victoria, Australia