Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea

Summary

The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the pharyngeal dilator muscles in patients with obstructive sleep apnoea in the community compared to usual care, and follow the patients for three months, as well as to assess compliance of non-invasive electrical stimulation of the upper airway dilator muscles in obstructive sleep apnoea patients over time and evaluate the control of symptoms and improvement in quality of life.

Conditions

• Obstructive Sleep Apnea

Interventions

DEVICE

Transcutaneous electrical stimulation

The device needs to be started by pressing the 'on' button. Once the device is turned on the current intensity can be increased by pushing the '+' button and lowered by pushing the '-' button. When a comfortable skin sensation is felt the patients should press the '-' button once more. At that time the device stimulates with a low current which is not felt but provides a neuromuscular tone to the muscles whilst asleep. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Once disconnected it should be turned off by pressing the 'off' button.

DEVICE

Continuous positive airway pressure

CPAP will be applied according to usual clinical care, the follow up will be organised in the same way as the active intervention group.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Joerg Steier, MD, PhD · Guy's and St Thomas' NHS Foundation Trust

• John Moxham, MD · King's College London

• Michael I Polkey, PhD · Royal Brompton & Harefield NHS Foundation Trust

• Kai Lee, MD · King's College London NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-18

Primary Completion

2023-02-08

Completion

2023-05-05

Countries

• United Kingdom

Study Locations