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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea of Adult

• Registration Number: NCT03048604
• Lead Sponsor: Nyxoah S.A.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-09
• Study Start: 2017-03-30
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Performance	6-months post implantation	Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)
Safety (Incidence of serious device-related adverse events)	6-months post implantation	Incidence of serious device-related adverse events

Trial Locations

Locations (3)

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

La Pitié Salpêtrière - Paris; 🇫🇷 Paris, France

Royal National Throat, Nose and Ear Hospital - London; 🇬🇧 London, United Kingdom