Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

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.

NCT Number	NCT07343362
Lead Sponsor	Zeus Sleep Ltd Collaborators: Guy's and St Thomas' NHS Foundation Trust, King's College London, Royal Brompton & Harefield NHS Foundation Trust, Queen Victoria Hospital NHS Foundation Trust, The Queen Elizabeth Hospital, Imperial College Healthcare NHS Trust, AintreeNHSTrust, University of Southampton, Royal Papworth Hospital
Conditions	Obstructive Sleep Apnea
Enrollment	186 participants
Start Date	2026-07-16
Primary Completion	2028-01-31 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-21