Evidence map›Paper›PMID 27435610›Full record

Trial reportThorax2016

Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea.

Martino F Pengo, Sichang Xiao, Culadeeban Ratneswaran, Kate Reed, Nimish Shah, Tao Chen, Abdel Douiri, Nicholas Hart, Yuanming Luo, Gerrard F Rafferty and 5 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01661712 nacompletednot on this map

Randomised, Double-blinded, Sham-controlled Cross-over Trial of Continuous Transcutaneous Electrical Stimulation of the Pharyngeal Dilator Muscles in Obstructive Sleep Apnoea

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2013 to 2015Enrolled44ConditionsObstructive Sleep ApnoeaArmsTranscutaneous electrical stimulation, Sham stimulation
NCT03160456 nacompletednot on this mapstarted 2018, after this paper: background citation

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

TypeinterventionalSponsorGuy's and St Thomas' NHS Foundation TrustRan2018 to 2023Enrolled56ConditionsObstructive Sleep ApneaArmsTranscutaneous electrical stimulation, Continuous positive airway pressure
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2021
    Guideline
  2. Pooled it
  3. Article
  4. Article
  5. Redefining Obstructive Sleep Apnea: Treatment in the Modern Era.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Non-CPAP therapy for obstructive sleep apnoea.Breathe (Sheffield, England) · 2022
    Review
  12. Review
  13. Review
  14. Review
  15. Practice Recommendations for Diagnosis and Treatment of the Most Common Forms of Secondary Hypertension.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2020
    Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 4 institutions in 3 countries.

Martino F PengoFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK Department of Medicine (DIMED), University of Padua, Padua, Italy.
Sichang XiaoFaculty of Life Sciences and Medicine, King's College London, London, UK State Key Laboratory of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Culadeeban RatneswaranFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK.
Kate ReedFaculty of Life Sciences and Medicine, King's College London, London, UK.
Nimish ShahFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK.
Tao ChenDivision of Health and Social Care, King's College London, London, UK.
Abdel DouiriDivision of Health and Social Care, King's College London, London, UK.
Nicholas HartFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK.
Yuanming LuoDepartment of Medicine (DIMED), University of Padua, Padua, Italy.
Gerrard F RaffertyFaculty of Life Sciences and Medicine, King's College London, London, UK.ORCID http://orcid.org/0000-0001-9520-6500
Gian Paolo RossiDepartment of Medicine (DIMED), University of Padua, Padua, Italy.
Adrian WilliamsFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK.
Michael I PolkeyNIHR Respiratory Biomedical Research Unit, The Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, UK.
John MoxhamFaculty of Life Sciences and Medicine, King's College London, London, UK.
Joerg SteierFaculty of Life Sciences and Medicine, King's College London, London, UK Guy's and St Thomas' NHS Foundation Trust, Lane Fox Respiratory Unit/Sleep Disorders Centre, London, UK.
King's College London · GBUniversity of Padua · ITGuy's and St Thomas' NHS Foundation Trust · GBRoyal Brompton & Harefield NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionObstructive sleep apnoea (OSA) is characterised by a loss of neuromuscular tone of the upper airway dilator muscles while asleep. This study investigated the effectiveness of transcutaneous electrical stimulation in patients with OSA. PATIENTS AND

methodsThis was a randomised, sham-controlled crossover trial using transcutaneous electrical stimulation of the upper airway dilator muscles in patients with confirmed OSA. Patients were randomly assigned to one night of sham stimulation and one night of active treatment. The primary outcome was the 4% oxygen desaturation index, responders were defined as patients with a reduction >25% in the oxygen desaturation index when compared with sham stimulation and/or with an index <5/hour in the active treatment night.

resultsIn 36 patients (age mean 50.8 (SD 11.2) years, male/female 30/6, body mass index median 29.6 (IQR 26.9-34.9) kg/m(2), Epworth Sleepiness Scale 10.5 (4.6) points, oxygen desaturation index median 25.7 (16.0-49.1)/hour, apnoea-hypopnoea index median 28.1 (19.0-57.0)/hour) the primary outcome measure improved when comparing sham stimulation (median 26.9 (17.5-39.5)/hour) with active treatment (median 19.5 (11.6-40.0)/hour; p=0.026), a modest reduction of the mean by 4.1 (95% CI -0.6 to 8.9)/hour. Secondary outcome parameters of patients' perception indicated that stimulation was well tolerated. Responders (47.2%) were predominantly from the mild-to-moderate OSA category. In this subgroup, the oxygen desaturation index was reduced by 10.0 (95% CI 3.9 to 16.0)/hour (p<0.001) and the apnoea-hypopnoea index was reduced by 9.1 (95% CI 2.0 to 16.2)/hour (p=0.004).

conclusionTranscutaneous electrical stimulation of the pharyngeal dilators during a single night in patients with OSA improves upper airway obstruction and is well tolerated. TRIAL REGISTRATION NUMBER: NCT01661712.

Indexed as

AdultAnthropometryCross-Over StudiesDouble-Blind MethodFemaleHumansHypoglossal NerveMaleMiddle AgedOxygenPolysomnographyRespiratory MusclesSleep Apnea, ObstructiveTranscutaneous Electric Nerve StimulationTreatment OutcomeOxygenSleep apnoea

Identifiers

PMID27435610
PMCPMC5036236
OpenAlexW2499858843

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.