Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea (TESLA-home)

Randomised Controlled Trial of Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Transcutaneous electrical stimulation; Device: Continuous positive airway pressure

Detailed Description

Obstructive sleep apnoea is highly prevalent, with the obesity epidemic increasing the problem. The best treatment for uncomplicated and moderate-severe OSA remains CPAP therapy. However, long-term adherence to treatment with CPAP is poor and there are few alternatives. Electrical stimulation of the dilator muscles of the upper airway has been shown to reduce nocturnal apnoeas significantly using an invasive approach, hypoglossal nerve stimulation, as well as by non-invasive transcutaneous stimulation. Although non-invasive transcutaneous stimulation may not be as effective as CPAP therapy in many OSA patients it could be an important option to treat some of the large number of patients who fail CPAP and might also be of use in those whose OSA is not judged sufficiently severe to warrant CPAP.

The investigators propose a study to use a transcutaneous electrical stimulation device in selected patients with OSA who do not tolerate CPAP therapy following assessment of the upper airway. Participants will undergo a baseline sleep study (polysomnography/home-based respiratory polygraphy). Following minimisation for gender (male/female) and OSA severity (mild/moderate-severe) they will be randomised into active treatment arm (transcutaneous electrical stimulation) or usual care (ongoing CPAP therapy). Patients will be treated over a period of 3-months in the community, re-assessed (including polysomnography/home-based respiratory polygraphy) and the results will be compared against usual care, ongoing CPAP therapy. This study will help to prepare a definitive multi-centre randomized controlled trial using the non-invasive method of upper airway stimulation in OSA.

The primary aim of this study is to assess efficacy and generate an accurate sample size estimation, test the subjective willingness of patients to use and objectively determined compliance with the treatment over a long period, as well as to specify the drop-out rate. The improvement in sleep apnoea will be the primary outcome measures. The symptomatic response, feasibility of the method, including compliance, comfort, adverse events, will be the secondary outcome measure. An ad-hoc analysis will be performed in the responder group (improvement in the apnoea-hypopnea index (AHI) by >50% from baseline OR improvement in the 4% oxygen-desaturation index (ODI) >25% from baseline OR AHI/4%ODI <5/hour at follow up).

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• mild-moderate OSA (AHI 5-35/hour)
• difficulties with or failed CPAP and/or withdrawn from standard care (CPAP <4hours/night)
• Body mass index (BMI) 18.5-32 kg/m2
• No significant anatomical obstruction in the upper airway (e.g. normal sized tonsils).

Exclusion Criteria:

• No OSA (AHI <5/h)
• Severe obstructive sleep apnoea (AHI>35/hour)
• Exclusively postural sleep apnoea
• isolated Rapid-Eye-Movement (REM) sleep associated OSA
• Cachexia (BMI <18.5 kg/m2)
• Obesity (BMI >32 kg/m2)
• Hypercapnic respiratory failure (pCO2>6.5 kPa)
• Features of obesity hypoventilation syndrome (elevated bicarbonate, HCO3- >28mmol/L).
• enlarged tonsils (size 3-4)
• polyps and adenoids
• neuromuscular disease
• hypoglossal nerve palsy
• abnormal pulmonary function tests
• severe pulmonary hypertension
• valvular heart disease
• heart failure (New York Heart Association, NYHA III-IV)
• myocardial infarction and significant cardiac arrhythmias
• uncontrolled hypertension
• active psychiatric disease
• co-existing non-respiratory sleep disorder
• significant metal implants or cardiac/other pacemakers.
• facial hair that affects the correct placement of the hydrogel patch
• endoscopically identified contraindication to upper airway stimulation (multi-level obstruction)

These criteria are consistent with our experience from previous trials using transcutaneous electrical stimulation in OSA and likely to identify potential responders; these criteria are also similar to those from trials using hypoglossal nerve stimulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous electrical stimulation; The group of participants receiving continuous transcutaneous electrical stimulation will be trained on the device and settings will be recorded. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At each visit comfort, compliance and adverse reactions will be recorded. At 12-weeks, the patients will be invited for a repeat assessment including polysomnography/home-based respiratory polygraphy during a night of electrical stimulation. Usage time of the device will be discussed with the patients and recorded.	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.; Other Names: TESLA home
Active Comparator: Continuous positive airway pressure (usual care); Participants who will be randomized to the usual care group will be given their own CPAP device, as previously prescribed. Bi-weekly phone calls and follow up visits at 6- and 12-weeks will be organized. At the last visit, the patients will be studied during a repeat inpatient polysomnography/home-based respiratory polygraphy and the initial assessment will be repeated.	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.; Other Names: CPAP (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnoea Hypopnoea Index	AHI	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale	ESS (0-24 points)	3 months
Oxygen Desaturation Index	4%ODI (x hour-1)	3 months
Usage of treatment	Usage per night (average hours)	3 months
Compliance with treatment	Percentage of nights used (%)	3 months
Acceptance of device	Visual analogue scale (points, 0-10)	3 months
Sleep related quality of life	FOSQ	3 months
Snoring	Percentage of the night (%)	3 months
Genioglossus contraction	Ultrasound (thickness, mm)	3 months
General quality of life	EQ-5D	3 months
Anatomy of upper airway	Endoscopically identified diameter (mm)	at baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	Reduction in AHI by more than 50% and / or to below 5/hour	3 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London; King's College Hospital NHS Trust; Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Michael I Polkey, PhD, Royal Brompton & Harefield NHS Foundation Trust; Principal Investigator: Joerg Steier, MD, PhD, Guy's and St Thomas' NHS Foundation Trust; Study Chair: John Moxham, MD, King's College London; Principal Investigator: Kai Lee, MD, King's College London NHS Foundation Trust

Publications and helpful links

General Publications

• Steier J, Seymour J, Rafferty GF, Jolley CJ, Solomon E, Luo Y, Man WD, Polkey MI, Moxham J. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011 Oct;140(4):998-1007. doi: 10.1378/chest.10-2614. Epub 2011 Mar 31.
• Pengo MF, Steier J. Emerging technology: electrical stimulation in obstructive sleep apnoea. J Thorac Dis. 2015 Aug;7(8):1286-97. doi: 10.3978/j.issn.2072-1439.2014.04.04.
• Bisogni V, Pengo MF, De Vito A, Maiolino G, Rossi GP, Moxham J, Steier J. Electrical stimulation for the treatment of obstructive sleep apnoea: a review of the evidence. Expert Rev Respir Med. 2017 Sep;11(9):711-720. doi: 10.1080/17476348.2017.1358619. Epub 2017 Jul 27.
• Pengo MF, Xiao S, Ratneswaran C, Reed K, Shah N, Chen T, Douiri A, Hart N, Luo Y, Rafferty GF, Rossi GP, Williams A, Polkey MI, Moxham J, Steier J. Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea. Thorax. 2016 Oct;71(10):923-31. doi: 10.1136/thoraxjnl-2016-208691. Epub 2016 Jul 19.
• Campbell T, Pengo MF, Steier J. Patients' preference of established and emerging treatment options for obstructive sleep apnoea. J Thorac Dis. 2015 May;7(5):938-42. doi: 10.3978/j.issn.2072-1439.2015.04.53.

Helpful Links

• Open access link to the first randomised sham-controlled study of TESLA
• Open access link to a review about invasive and non-invasive electrical stimulation in sleep apnoea

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: sleep; electrical stimulation; CPAP; sleep disordered breathing; upper airway; genioglossus
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Version 1.3 / 22-11-2020; 217448 (Other Identifier: IRAS); 18/LO/0638 (Other Identifier: REC reference)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes, upon request to the authors.
• IPD Sharing Time Frame: The study protocol has been published (Journal of Thoracic Disease 05/2019)
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Study Data/Documents

1. NICE guidance "Hypoglossal Nerve Stimulation"
   Information identifier: IPG598
   Information comments: National Institute for Health and Care Excellence

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No