A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults (EliSA)

Nyxoah

Status: Active, not recruiting

Conditions: Obstructive Sleep Apnea

Treatments: Device: Genio® system therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04031040

CL-GEN-002068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

Genio® system therapy

Experimental group

Description:

Following activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.

Treatment:

Device: Genio® system therapy