Feasibility of Upper Airway Stimulation in OSA

Feasibility of Non-invasive Electrical Nerve Stimulation of the Upper Airway in Patients With Obstructive Sleep Apnoea

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.

Inclusion Criteria:

• 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 Criteria:

• 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)