New device could help sleep apnoea patients ditch CPAP masks

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour, as measured by the baseline sleep study (3 nights off CPAP). 2. If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours/night on fewer than 70% of nights over a minimum period of 3 months prior to enrolment. 3. Adults with a body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive) 4. Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils). 5. Able and willing to provide informed written consent. 6. Access to a smartphone and internet at home. Exclusion Criteria: 1. Hypercapnic patients (pCO2\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \>28mmol/L). 2. Adults with significantly enlarged tonsils (size 3-4) 3. Adults with polyps or adenoids, hypoglossal nerve palsy, 4. Adults with notable medical co-morbidities that could potentially impact participation in or the achievement of the study's objectives (e.g., significant heart failure (New York Heart Association, NYHA class III-IV), recent myocardial infarction (within 3 months) and significant cardiac arrhythmias, uncontrolled hypertension). 5. Participants with an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data. 6. Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps. 7. Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device. 8. Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device 9. Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave. 10. Participants with an allergy to plasters or similar products.