Safety and Performance Study of the Nyxoah SAT System for Treating OSA
Not Applicable
Terminated
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Nyxoah SAT system
- Registration Number
- NCT02312479
- Lead Sponsor
- Nyxoah S.A.
- Brief Summary
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Diagnosed with moderate to severe Obstructive Sleep Apnea
- Have failed or have not tolerated CPAP treatment
- Willing and capable of providing informed consent
- Willing and capable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
Exclusion Criteria
- BMI limits
- Subjects with complete concentric collapse at the soft palate level per endoscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nyxoah SAT therapy Nyxoah SAT system -
- Primary Outcome Measures
Name Time Method Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation 6-months post-implantation Incidence of serious device related adverse events 6-months post-implantation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Antwerp University Hospital
🇧🇪Edegem, Belgium
Universitäts-HNO-Klinik Mannheim
🇩🇪Mannheim, Germany