Obstructive Sleep Apnea of Adult
Conditions
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).
Interventions
Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.
Sponsors
Nyxoah S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Incidence of serious device-related adverse events) | 6-months post implantation | Incidence of serious device-related adverse events |
| Performance | 6-months post implantation | Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI) |
Countries
Australia, France, United Kingdom
Outcome results
None listed