Domiciliary Transcutaneous Electrical Stimulation in Obstructive Sleep Apnoea

Obstructive Sleep Apnea Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160456
• Other study ID #: Version 1.3 / 22-11-2020
• Secondary ID: 21744818/LO/0638
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 5, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' NHS Foundation Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College Hospital NHS Trust, King's College London, Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Thor — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Responder rate	Reduction in AHI by more than 50% and / or to below 5/hour	3 months
Primary	Apnoea Hypopnoea Index	AHI	3 months
Secondary	Epworth Sleepiness Scale	ESS (0-24 points)	3 months
Secondary	Oxygen Desaturation Index	4%ODI (x hour-1)	3 months
Secondary	Usage of treatment	Usage per night (average hours)	3 months
Secondary	Compliance with treatment	Percentage of nights used (%)	3 months
Secondary	Acceptance of device	Visual analogue scale (points, 0-10)	3 months
Secondary	Sleep related quality of life	FOSQ	3 months
Secondary	Snoring	Percentage of the night (%)	3 months
Secondary	Genioglossus contraction	Ultrasound (thickness, mm)	3 months
Secondary	General quality of life	EQ-5D	3 months
Secondary	Anatomy of upper airway	Endoscopically identified diameter (mm)	at baseline

External Links

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