BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

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).

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hollywood Private UWA Centre for Sleep Science Facility, Nedlands, Perth, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main 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

Main 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

Treatment and study plan

Genio(TM) bilateral hypoglossal nerve stimulation system

Device

Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.

Primary outcomes

Safety (Incidence of serious device-related adverse events)

Time frame: 6-months post implantation

Incidence of serious device-related adverse events
Performance

Time frame: 6-months post implantation

Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)

Sponsors and collaborators

Lead sponsor

Nyxoah S.A.

Industry

Registry information

Official study title

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.

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 9, 2017
Registry last updated: Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed