A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.

Nyxoah S.A.3 sites in 3 countries27 target enrollmentMarch 30, 2017

ConditionsObstructive Sleep Apnea of Adult

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea of Adult
Sponsor: Nyxoah S.A.
Enrollment: 27
Locations: 3
Primary Endpoint: Performance
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 30, 2017

End Date

September 10, 2018

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nyxoah S.A.

Responsible Party

Sponsor

Eligibility Criteria

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

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