Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
Overview
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Apnex Medical, Inc.
- Enrollment
- 132
- Locations
- 14
- Primary Endpoint
- Safety Analysis
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Criteria
- Not provided
Outcomes
Primary Outcomes
Safety Analysis
Time Frame: 12 months
Description of all adverse events
Reduction in OSA Severity
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported