NCT03048604CompletedNot Applicable
A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.
Nyxoah S.A.3 sites in 3 countries27 target enrollmentStarted: March 30, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 3
- Primary Endpoint
- Performance
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main 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
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
Outcomes
Primary Outcomes
Performance
Time Frame: 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)
Time Frame: 6-months post implantation
Incidence of serious device-related adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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