Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

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

Interventions

DEVICE

ZeusOSA

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

DEVICE

CPAP

Continous positive airway pressure (CPAP) when asleep

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Queen Victoria Hospital NHS Foundation Trust

  collaborator OTHER_GOV

• The Queen Elizabeth Hospital

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• AintreeNHSTrust

  collaborator UNKNOWN

• University of Southampton

  collaborator OTHER

• Royal Papworth Hospital

  collaborator OTHER_GOV

• Zeus Sleep Ltd

  lead INDUSTRY

Principal Investigators

• Joerg Steier, PhD · Guy's & St Thomas' NHS Foundation Trust, London, UK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-16

Primary Completion

2028-01-31

Completion

2028-09-30