BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03048604 |
Recruitment Status :
Completed
First Posted : February 9, 2017
Last Update Posted : October 11, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea of Adult | Device: Genio(TM) bilateral hypoglossal nerve stimulation system | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | March 30, 2017 |
Actual Primary Completion Date : | September 10, 2018 |
Actual Study Completion Date : | September 10, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Genio(TM) system therapy |
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. |
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048604
Australia, Perth | |
Hollywood Private UWA Centre for Sleep Science Facility | |
Nedlands, Perth, Australia | |
France | |
La Pitié Salpêtrière - Paris | |
Paris, France | |
United Kingdom | |
Royal National Throat, Nose and Ear Hospital - London | |
London, United Kingdom |
Principal Investigator: | Valérie Attali, Dr. | La Pitié Salpêtrière, Paris |
Responsible Party: | Nyxoah S.A. |
ClinicalTrials.gov Identifier: | NCT03048604 |
Other Study ID Numbers: |
BLAST OSA |
First Posted: | February 9, 2017 Key Record Dates |
Last Update Posted: | October 11, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |