TESLA-MICRONZeusOSA Device for Obstructive Sleep Apnoea Treatment in Poor CPAP Adherence
This study aims to evaluate the ZeusOSA device as a treatment for obstructive sleep apnoea, specifically for individuals who have poor adherence to Continuous Positive Airway Pressure (CPAP) therapy.
ZeusOSA
+ CPAP
Apnea+6
+ Nervous System Diseases
+ Respiration Disorders
Treatment Study
Summary
Study start date: July 16, 2026
Actual date on which the first participant was enrolled.The TESLA-MICRON study is a UK-based research project focused on adults who have obstructive sleep apnoea and struggle with using continuous positive airway pressure (CPAP) therapy. The study aims to evaluate the effectiveness of an investigational device called ZeusOSA. This device uses gentle electrical stimulation through the skin, similar to a TENS machine, to help keep the airways open during sleep. The importance of this study lies in finding a potential solution for those who have difficulty using CPAP machines, thereby improving their sleep quality and overall health. 186 participants with a prior diagnosis of obstructive sleep apnoea and low CPAP adherence will be divided into two groups. One group will use the ZeusOSA device nightly at home for three months, while the other group will continue with their usual CPAP therapy. The ZeusOSA device delivers mild electrical stimulation to the muscles that open the airways, preventing them from relaxing and causing sleep apnoea or snoring. The stimulation level can be adjusted from mild to strong. All participants will have baseline and follow-up assessments, including home-based sleep studies. The study will assess the effects of the device on sleep-related outcomes, symptoms, and quality of life. It will also evaluate treatment adherence, comfort, and any adverse events.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.186 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour. 2. If participant fails to use CPAP sufficiently with less than 4 hours/night. 3. Adults with a body mass index (BMI) of 18.5-32.0 kg/m2, 4. Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils). 5. Able to provide informed consent. Exclusion Criteria: 1. Adults with no OSA (AHI \<5/h), or with very severe OSA (AHI\>40/hour). 2. Adults who are cachectic (BMI \<18.5 kg/m2) or very obese (BMI \>32 kg/m2). 3. Hypercapnic patients (pCO2\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \>28mmol/L). 4. Adults should not have significantly enlarged tonsils (size 3-4) 5. Adults with polyps or adenoids, hypoglossal nerve palsy, 6. 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). 7. Participants with active psychiatric disease. 8. Adults with significant metal implants in head / neck, or cardiac/other pacemakers. 9. Participants who are physically incapacitated such as to manoeuvre the Zeus device 10. Adults who do not have access to a smartphone and/or internet data at home.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active Comparator