BLAST OSA study version 01
Research type
Research Study
Full title
A multicenter, prospective, open-label, non-randomised, 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 Apnea (BLAST OSA).
IRAS ID
218279
Contact name
Bhik Kotecha
Contact email
Sponsor organisation
Nyxoah S.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
The BLAST OSA study is a study in adult patients suffering from obstructive sleep apnoea (OSA). OSA is characterised by a loss of muscle tone during sleep, causing multiple occurances of partial or complete upper airway blockage and thus difficulty breathing. The most common treatment is Continuous Positive Airway Pressure (CPAP), a ventilation device that blows air into the nose through a mask placed over the nose or nose and mouth during sleep to keep the airway open. It is effective but often not liked by patients. \nThis study aims to assess the safety, performance and initial efficacy trends of the Genio(TM) System for the treatment of moderate to severe OSA in patients who have either failed and/or do not tolerate CPAP therapy. The Genio(TM) System includes an implantable stimulator implanted during a surgical procedure in the chin area and is designed to stimulate the nerve of the tongue, called the hypoglossal nerve. The implant does not include a battery and receives energy from an activation chip which is attached to an adhesive disposable patch and placed under the chin. Stimulation of the hypoglossal nerve causes the contraction of the tongue muscles. This process can help to open airway and maintain normal breathing while sleeping. \nIt is planned that 25 subjects will be included, from approximately 8 centres in Europe and Australia. \nThe study is split into 2 phases. The first phase will last about 8 months (including a 5-month treatment period) for each participant. They will need to visit the clinic at least 7 times and will receive 2 phone calls. The second phase is an optional follow up period (until granting of European Approval (CE mark)) to collect additional information on the device safety.
REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0077
Date of REC Opinion
4 Sep 2017
REC opinion
Further Information Favourable Opinion