BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea of Adult
- Interventions
- Device: Genio(TM) bilateral hypoglossal nerve stimulation system
- Registration Number
- NCT03048604
- Lead Sponsor
- Nyxoah S.A.
- Brief Summary
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Body mass index ≤32 kg/m2
- Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.
- Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour
Main
Exclusion Criteria
- Unable or incapable of providing informed written consent
- Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
- Significant co-morbidities making the patient unable or inappropriate to participate in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Genio(TM) system therapy Genio(TM) bilateral hypoglossal nerve stimulation system -
- Primary Outcome Measures
Name Time Method Performance 6-months post implantation Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)
Safety (Incidence of serious device-related adverse events) 6-months post implantation Incidence of serious device-related adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Royal National Throat, Nose and Ear Hospital - London
🇬🇧London, United Kingdom
Hollywood Private UWA Centre for Sleep Science Facility
🇦🇺Nedlands, Perth, Australia
La Pitié Salpêtrière - Paris
🇫🇷Paris, France