Feasibility of Upper Airway Stimulation in OSA
Recruiting now · Not applicable
Conditions studied: Obstructive Sleep Apnoea (OSA)
In brief
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.
Key facts
- Study ID
- NCT07396649
- Run by
- Notos Medical Limited
- People needed
- 15
- Starts
- 2026-01-29
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-02-09
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Presence of a cardiac pacemaker or implantable cardiac defibrillator or ventriculoperitoneal shunt
- 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
- A diagnosis of periodic leg movement disorder
- Awake resting arterial oxygen saturation <93% (suggesting possible hypoventilation)
- Unstable, untreated coronary or peripheral artery disease
- Severe arterial hypertension defined as a resting blood pressure (BP) of >180/110mmHg
- Currently employed as a professional driver
- Any previous sleep-related driving accident
- A past or current condition that in the opinion of the investigator contraindicates enrolment (e.g. chronic substance abuse, severe psychiatric disorders)
Where it is running
- Antwerp University Hospital — Edegem, Belgium (enrolling)
Full record on ClinicalTrials.gov
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