Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

NCT07343362 | Not Yet Recruiting DMC

• 2 other identifiers: ZEUSi4i-1.0-03/12/25NIHR209411
• Study Type: interventional
• Target: 186
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

CPAP; Continuous Positive Airway Pressure; Hypoglossal Nerve Stimulation; non-CPAP therapy; sleep-disordered breathing; TESLA-MICRON; Zeus Sleep Technology; transcutaneous electrical stimulation; Zeus Sleep Ltd

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea-index (AHI)

  Number of respiratory events per hour measured by home-based sleep study.

  Baseline to 3 months

Secondary Outcomes (9)

• Epworth Sleepiness Scale (ESS)

  Baseline to 3 months

• EQ-5D Index Score

  Baseline to 3 months

• EQ-5D Visual Analogue Scale (VAS) Score

  Baseline to 3 months

• Functional Outcome of Sleep Questionnaire (FOSQ-10) Score

  Baseline to 3 months

• Snoring Duration

  Baseline to 3 months

Other Outcomes (5)

• SHER15 criteria defining responders to treatment

  3-months

• SHER20 criteria defining responders to treatment

  3-months

• Gender-related response

  3-months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Continuous Positive Airway Pressure (CPAP)

Device: CPAP

Intervention

EXPERIMENTAL

Transcutaneous Electrical Stimulation (ZeusOSA)

Device: ZeusOSA

Interventions

ZeusOSA DEVICE

Transcutaneous electrical stimulation in sleep apnoea (TESLA) in the submittal area, provided by the ZeusSleep device when asleep.

Intervention

CPAP DEVICE

Continous positive airway pressure (CPAP) when asleep

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants (≥18 years) who have OSA with an AHI between 5-40 events/hour, as measured by the baseline sleep study (3 nights off CPAP).
• If the participant fails to use CPAP sufficiently, defined as use of CPAP for less than 4 hours/night on fewer than 70% of nights over a minimum period of 3 months prior to enrolment.
• Adults with a body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive)
• Adults without significant anatomical obstruction in the upper airway (e.g., normal sized tonsils).
• Able and willing to provide informed written consent.
• Access to a smartphone and internet at home.

You may not qualify if:

• Hypercapnic patients (pCO2\>6.0 kPa) or those with other features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- \>28mmol/L).
• Adults with 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 an active psychiatric condition that, in the opinion of the Investigator, may affect the participant's capacity to provide informed consent, adhere to study procedures, actively participate in the study, or compromise the integrity of study data.
• Participants with active implantable medical devices, including but not limited to cardiac pacemakers, implantable cardioverter defibrillators (ICDs), cochlear implants, deep brain stimulation (DBS) systems, vagus nerve stimulation (VNS) devices, neurostimulators, or implanted infusion pumps.
• Participants with metallic implants in the head or neck region that, in the opinion of the Investigator, may interfere with the safe use of the investigational device.
• Participants who are physically incapacitated such as to manoeuvre the ZeusOSA device
• Adults with long facial hair that interferes with the correct placement of the hydrogel pad, and who are unwilling to shave.
• Participants with an allergy to plasters or similar products.

Sponsors & Collaborators

• Zeus Sleep Ltd: lead
• King's College London: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Queen Victoria Hospital NHS Foundation Trust: collaborator
• The Queen Elizabeth Hospital: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• AintreeNHSTrust: collaborator
• University of Southampton: collaborator
• Royal Papworth Hospital: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Joerg Steier, PhD

  Guy's & St Thomas' NHS Foundation Trust, London, UK

  STUDY CHAIR

Central Study Contacts

Nigel Clarke, CEO

CONTACT

+442071883434; support@zeussleeps.com

Salma Ayyis, PhD

CONTACT

+442071882823

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The analysis of the sleep studies will be undertaken by an independent party (outsourced data provider) and allocation to the RCT arms will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-group, parallel, interventional randomized controlled trial Sample Size Calculation The sample size estimates were based on the previous trial by Ratneswaran et al. 2023 (eClinMed) where the primary outcome was change in mean apnea-hypopnea index (AHI) at 3-months between two trial arms. The difference adjusted for the baseline value was -7.0 (95% CI: -15.7;1.8), and the common standard deviation within group was 18. Using these estimates for an analysis of covariance, sample sizes of 74, and 74 are required from each of the 2 trial groups whose means are to be compared. The covariate was assumed to have an R-squared of 0.30. The total sample of 148 subjects achieves 80% power to detect the differences described by Ratneswaran between the two means, with 0.05 00 significance level. Allowing for 20% dropout the sample required is 186 participants in the two groups.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 15, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07