Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea

NCT ID: NCT03160456

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2023-05-05

Brief 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.

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).

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous electrical stimulation

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

TESLA home; CPAP (usual care)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Joerg Steier

Consultant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joerg Steier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

John Moxham, MD

Role: STUDY_CHAIR

King's College London

Michael I Polkey, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Kai Lee, MD

Role: PRINCIPAL_INVESTIGATOR

King's College London NHS Foundation Trust

Locations

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 26380757 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28730908 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27435610 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26101652 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21454399 (View on PubMed)

Ratneswaran D, Cheng M, Nasser E, Madula R, Pengo M, Hope K, Schwarz EI, Luo Y, Kaltsakas G, Polkey MI, Moxham J, Steier J. Domiciliary transcutaneous electrical stimulation in patients with obstructive sleep apnoea and limited adherence to continuous positive airway pressure therapy: a single-centre, open-label, randomised, controlled phase III trial. EClinicalMedicine. 2023 Aug 3;62:102112. doi: 10.1016/j.eclinm.2023.102112. eCollection 2023 Aug.

Reference Type: DERIVED

PMID: 37654667 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Study Documents

Document Type: NICE guidance "Hypoglossal Nerve Stimulation"

National Institute for Health and Care Excellence

View Document

Related Links

http://thorax.bmj.com/content/71/10/923.long

Open access link to the first randomised sham-controlled study of TESLA

http://jtd.amegroups.com/article/view/2429/5199

Open access link to a review about invasive and non-invasive electrical stimulation in sleep apnoea

Other Identifiers

217448

Identifier Type: OTHER

Identifier Source: secondary_id

18/LO/0638

Identifier Type: OTHER

Identifier Source: secondary_id

Version 1.3 / 22-11-2020

Identifier Type: -

Identifier Source: org_study_id