Obstructive Sleep Apnea
Conditions
Brief summary
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
Detailed description
This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.
Interventions
DEVICEGenio® system therapy
Hypoglossal nerve stimulation system
Sponsors
Nyxoah S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) \< 35 kg/m2 * AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase. * Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.
Exclusion criteria
* Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment; * Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture; * Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA; * Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing; * Life expectancy \< 12 months; * Participation in another clinical study (excluding registries) during the study period (3 years).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related Serious Adverse Events (SADEs) | 12 months post-surgery | Incidence of device-related Serious Adverse Events (SADEs) |
| Change in Apnea-Hypopnea Index from baseline | 12 months post-surgery | Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab |
| Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire | 12 months post-surgery | Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ) |
Countries
Belgium, France, Germany, Netherlands, Switzerland
Contacts
PRINCIPAL_INVESTIGATORJoachim T. Maurer, MD
Klinik für HNO-Heilkunde, Mannheim
Outcome results
None listed