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.
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Eligibility Criteria
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 c…
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)
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