Obstructive Sleep Apnea
Conditions
Keywords
Apnea, OSA, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Hypoglossal Nerve Stimulation, Sleep Disorders, Tongue
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.
Interventions
DEVICEHypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )
The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
Sponsors
Apnex Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Safety Analysis | 12 months | Description of all adverse events |
Countries
Australia, United States
Outcome results
None listed