Targeted Hypoglossal Neurostimulation Study #3
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT02263859
- Lead Sponsor
- ImThera Medical, Inc.
- Brief Summary
The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.
- Detailed Description
The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI \> 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- Age >18 years
- Individual has failed or does not tolerate PAP therapy
- Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)
- AHI ≥ 20 (Moderate to severe OSA)
Exclusion Critera:
- Implanted with another active implantable device
- Body mass index (BMI) ≥ 35 kg/m²
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Improvement in Oxygen Desaturation Index (ODI) Baseline to 4 months post-implant Proportion of subjects who experience improvement in the oxygen desaturation index 4% (ODI 4%) at the Month 4 visit as defined above in the ODI Responder definition.
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.Improvement in Apnea Hypopnea Index (AHI) Baseline to 4 months post-implant Proportion of subjects who experience improvement in the apnea-hypopnea index (AHI) at the Month 4 visit as defined above in the AHI Responder definition.
It is hypothesized that the observed responder rate in the Treatment Group will be significantly greater than the responder rate in the Control Group at 4 months post-implant.Safety Analysis Baseline to 12 months post-implant Estimate the incidence of serious adverse events (SAEs) related to the aura6000 device or procedure, including any unanticipated adverse device effects.
- Secondary Outcome Measures
Name Time Method Change in Epworth Sleepiness Scale (ESS) Baseline to 4 months post-implant Change in Functional Outcomes of Sleep (FOSQ) Baseline to 4 months post-implant Change in EuroQol 5 Dimensional (EQ-5D) Baseline to 4 months post-implant Long-term Responder Rate Baseline to 12 months post-implant
Trial Locations
- Locations (20)
ENT Associates of San Diego
🇺🇸Chula Vista, California, United States
Tower ENT
🇺🇸Los Angeles, California, United States
SENTA Clinic
🇺🇸San Diego, California, United States
Ear, Nose, and Throat Associates of South Florida
🇺🇸Boca Raton, Florida, United States
Morton Plant Mease Healthcare
🇺🇸Safety Harbor, Florida, United States
Advanced ENT Asociates
🇺🇸Atlanta, Georgia, United States
Center for ENT and Allergy
🇺🇸Carmel, Indiana, United States
Kentucky Research Group
🇺🇸Louisville, Kentucky, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
ENT and Allergy Associates
🇺🇸New York, New York, United States
Scroll for more (10 remaining)ENT Associates of San Diego🇺🇸Chula Vista, California, United States