Domiciliary transcutaneous electrical stimulation in OSA
Research type
Research Study
Full title
Randomised controlled trial of domiciliary transcutaneous electrical stimulation in obstructive sleep apnoea: TESLA-home
IRAS ID
217448
Contact name
Joerg Steier
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
The most common problem breathing at night is obstructive sleep apnoea (OSA). OSA is frequently associated with snoring and with obesity. Patients with OSA stop breathing for long periods until sleep is disturbed. This fragments sleep and leaves patients sleepy by daytime.
The best treatment to control OSA and avoid breath holding when asleep is continuous positive airway pressure (CPAP) therapy. CPAP requires the patient to sleep with a mask over the face to apply pressure to the airway. However, long-term CPAP compliance is limited and there are few effective alternative treatments.
Electrical stimulation of the muscles that keep the upper airway open while asleep, particularly the genioglossus muscle, has been shown to improve OSA. Stimulation can be used with an invasive approach, hypoglossal nerve stimulation, as well as by external stimulation. Although electrical stimulation may not be as effective as CPAP therapy it could be an important option to treat patients who fail standard CPAP therapy and those whose condition is not judged sufficiently severe to offer CPAP.
We propose to test the use of an external electrical stimulation device, similar to a transcutaneous electrical neurostimulator (TENS) machine, in patients with OSA who do not tolerate CPAP therapy; we will study patients over a period of 3-months. The results of this study will help us to assess efficacy of the treatment and symptomatic improvement, as well as to prepare for a definitive multi-centre and randomized controlled trial.
The primary aim is to assess efficacy, objectively determine compliance with the treatment, as well as to specify the number of patients who are recruited and those who stop the treatment. Compliance with the treatment, improvement in symptoms like sleepiness, and control of sleep apnoea severity will be the tested outcome measures.
REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/0638
Date of REC Opinion
13 Jun 2018
REC opinion
Further Information Favourable Opinion