NCT03160456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

4.6 years

First QC Date

May 16, 2017

Last Update Submit

May 5, 2023

Conditions

Obstructive Sleep Apnea

Keywords

upper airwaygenioglossusCPAPelectrical stimulationsleepsleep disordered breathing

Outcome Measures

Primary Outcomes (1)

  • Apnoea Hypopnoea Index

    AHI

    3 months

Secondary Outcomes (10)

  • Epworth Sleepiness Scale

    3 months

  • Oxygen Desaturation Index

    3 months

  • Usage of treatment

    3 months

  • Compliance with treatment

    3 months

  • Acceptance of device

    3 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Responder rate

    3 months

Study Arms (2)

Transcutaneous electrical stimulation

EXPERIMENTAL

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

Continuous positive airway pressure (usual care)

ACTIVE COMPARATOR

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

Interventions

Transcutaneous electrical stimulationDEVICE

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.

Also known as: TESLA home
Transcutaneous electrical stimulation
Continuous positive airway pressureDEVICE

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

Also known as: CPAP (usual care)
Continuous positive airway pressure (usual care)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (6)

  • 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.

    PMID: 26380757BACKGROUND

  • 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.

    PMID: 28730908BACKGROUND

  • 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.

    PMID: 27435610RESULT

  • 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.

    PMID: 26101652RESULT

  • 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.

    PMID: 21454399RESULT

  • 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.

    PMID: 37654667DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Transcutaneous Electric Nerve StimulationContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaPositive-Pressure RespirationRespiration, ArtificialAirway ManagementRespiratory Therapy

Study Officials

  • Joerg Steier, MD, PhD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • John Moxham, MD

    King's College London

    STUDY CHAIR

  • Michael I Polkey, PhD

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Kai Lee, MD

    King's College London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised parallel group controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

June 18, 2018

Primary Completion

February 8, 2023

Study Completion

May 5, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Yes, upon request to the authors.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The study protocol has been published (Journal of Thoracic Disease 05/2019)
Access Criteria
Upon request
More information

Available IPD Datasets

NICE guidance "Hypoglossal Nerve Stimulation" (IPG598)Access

Locations

GB(1)