Obstructive Sleep Apnea
Conditions
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
Interventions
DEVICENyxoah SAT system
The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.
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 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious device related adverse events | 6-months post-implantation |
| 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 |
Countries
Belgium, Germany
Outcome results
None listed