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

Obstructive Sleep Apnea of Adult Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048604
• Other study ID #: BLAST OSA
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: October 2021
• Source: Nyxoah S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Genio(TM) bilateral hypoglossal nerve stimulation system
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.

Locations

Country	Name	City	State
Australia	Hollywood Private UWA Centre for Sleep Science Facility	Nedlands	Perth
France	La Pitié Salpêtrière - Paris	Paris
United Kingdom	Royal National Throat, Nose and Ear Hospital - London	London

Sponsors (1)

Lead Sponsor	Collaborator
Nyxoah S.A.

Countries where clinical trial is conducted

Australia,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Incidence of serious device-related adverse events)	Incidence of serious device-related adverse events	6-months post implantation
Primary	Performance	Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI)	6-months post implantation