CompletedNo phase
Feasibility of Upper Airway Stimulation in OSA
Key facts
- Who runs it
- Notos Medical Limited
- Where
- Belgium1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 17 people enrolled
- Started
- 29 Jan 2026
- Ended
- 27 Aug 2026
- Type of study
- Interventional
- Treatments tested
- Non-invasive electrical stimulation
- Record updated
- 10 November 2026
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Obstructive sleep apnoea diagnosis with an AHI of 15-50 events/hour recorded in the baseline polysomnography (PSG)
- BMI < 32 kg/m²
- Age > 18 years old
- Able to read, write, and speak Dutch with acceptable visual and auditory acuity
- Able and willing to provide informed consent
Who cannot take part
- Any previous sleep-related driving accident
- Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
- A diagnosis of periodic leg movement disorder
- Unstable, untreated coronary or peripheral artery disease
- Severe arterial hypertension defined as a resting blood pressure (BP) of >180/110mmHg
- A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
- Central (non-obstructive) AHI episodes >5 events/hour recorded in the baseline PSG
- Inability to sleep supine
- Pregnancy
- Inability to undergo DISE
- Inability or unwillingness to shave under and around their chin and neck if appropriate
- Known inability to complete PSG with a total sleep time of > 4 hours
- The use of other neurostimulatory devices
- Awake resting arterial oxygen saturation <93% (suggesting possible hypoventilation)
- Currently employed as a professional driver
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Project Breathe 1 is a short-duration (5 month) pilot investigation to assess the safety and tolerability of non-invasive electrical stimulation in adults with obstructive sleep apnoea. The investigation is an unblinded, uncontrolled, single arm design.
The group in the trial
- Non-invasive electrical stimulation of the upper airwayTreatment being tested
Participants will have bilateral non-invasive electrical stimulation of the submandibular region while undergoing a polysomnography assessment and during drug induced sleep endoscopy.
Treatment: Non-invasive electrical stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
- Record updated
- 10 November 2026