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

Nyxoah

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Genio(TM) 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, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 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 a PSG during the screening phase.
• Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

Exclusion criteria

• Night shift worker
• Significant comorbidities that contraindicates surgery
• 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)

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110 participants in 1 patient group

Genio(TM) 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(TM) system therapy