Feasibility of Upper Airway Stimulation in OSA
Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea
Notos Medical Limited
15 participants
Jan 29, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria15
- 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)
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Interventions
The non-invasive electrical stimulation components will consist of two Digitimer DS5 isolated current stimulators, voltage control by an NI-9262 module, and two pairs of adhesive electrodes placed in the submandibular region.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07396649