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 range18 Years
SexALL
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).
✕. 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.