Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

Sponsor
Zeus Sleep Ltd
Study ID
NCT07343362
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZeusOSA — DEVICE
    Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.
  • CPAP — DEVICE
    Continous positive airway pressure (CPAP) when asleep

Study Details

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.

Key Dates

First listed
Jan 15, 2026
Start date
Jul 16, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Usual Care
    Continuous Positive Airway Pressure (CPAP)
  • Experimental: Intervention
    Transcutaneous Electrical Stimulation (ZeusOSA)

Primary Outcome Measure

Apnea-hypopnea-index (AHI) [ Time Frame: Baseline to 3 months ]

Central Contacts

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