Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea (NCT07343362) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
186 participantsStarted 2026-07-16
Plain-language summary
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (CPAP) therapy over a period of 3-months in the community and compare results against usual care (ongoing CPAP therapy), evaluate acceptability, comfort and adverse events, and record outcomes for provision of the health economics analysis. The proposed study will provide us with data about the efficacy of the domiciliary use of the intervention from a UK-based prospective, multi-centre and randomised controlled trial (Phase III). We will understand whether the primary outcome parameter, the apnoea hypopnea index (AHI), or the secondary outcomes (e.g., 4% oxygen desaturation index (ODI), the Epworth Sleepiness Scale (ESS), compliance and comfort, functional outcome of sleep questionnaires (FOSQ), European Quality of Life Questionnaire (EQ-5D)) are suitable measures to assess control of OSA using TESLA within reasonable acceptance for the patients to provide the analysis of healthcare resource usage for assessment of cost-efficacy and quality-adjusted life years (QALYs). Responder analysis will provide insights into gender, socio-economic background and endotypes to predict who most suitably benefits from this treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour.
. If participant fails to use CPAP sufficiently with less than 4 hours/night.
. Adults with a body mass index (BMI) of 18.5-32.0 kg/m2,
. Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).
. Able to provide informed consent.
Exclusion criteria
. Adults with no OSA (AHI \<5/h), or with very severe OSA (AHI\>40/hour).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adults who are cachectic (BMI \<18.5 kg/m2) or very obese (BMI \>32 kg/m2).
. Hypercapnic patients (pCO2\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \>28mmol/L).
. Adults should not have significantly enlarged tonsils (size 3-4)
. Adults with polyps or adenoids, hypoglossal nerve palsy,
. 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).
. Participants with active psychiatric disease.
. Adults with significant metal implants in head / neck, or cardiac/other pacemakers.