title: Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea.
abstract: BACKGROUND
  Obstructive 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  In 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).
  
  
  CONCLUSIONS
  Transcutaneous electrical stimulation of the pharyngeal dilators during a single night in patients with OSA improves upper airway obstruction and is well tolerated.
  
  
  BACKGROUND
  NCT01661712.
authors.affiliation: Faculty 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.
authors.forename: Martino F
authors.initials: MF
authors.lastname: Pengo
authors.affiliation: Faculty 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.
authors.forename: Sichang
authors.initials: S
authors.lastname: Xiao
authors.affiliation: Faculty 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.
authors.forename: Culadeeban
authors.initials: C
authors.lastname: Ratneswaran
authors.affiliation: Faculty of Life Sciences and Medicine, King's College London, London, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Reed
authors.affiliation: Faculty 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.
authors.forename: Nimish
authors.initials: N
authors.lastname: Shah
authors.affiliation: Division of Health and Social Care, King's College London, London, UK.
authors.forename: Tao
authors.initials: T
authors.lastname: Chen
authors.affiliation: Division of Health and Social Care, King's College London, London, UK.
authors.forename: Abdel
authors.initials: A
authors.lastname: Douiri
authors.affiliation: Faculty 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.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Hart
authors.affiliation: Department of Medicine (DIMED), University of Padua, Padua, Italy.
authors.forename: Yuanming
authors.initials: Y
authors.lastname: Luo
authors.affiliation: Faculty of Life Sciences and Medicine, King's College London, London, UK.
authors.forename: Gerrard F
authors.identifier: http://orcid.org/0000-0001-9520-6500
authors.initials: GF
authors.lastname: Rafferty
authors.affiliation: Department of Medicine (DIMED), University of Padua, Padua, Italy.
authors.forename: Gian Paolo
authors.initials: GP
authors.lastname: Rossi
authors.affiliation: Faculty 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.
authors.forename: Adrian
authors.initials: A
authors.lastname: Williams
authors.affiliation: NIHR Respiratory Biomedical Research Unit, The Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London, UK.
authors.forename: Michael I
authors.initials: MI
authors.lastname: Polkey
authors.affiliation: Faculty of Life Sciences and Medicine, King's College London, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Moxham
authors.affiliation: Faculty 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.
authors.forename: Joerg
authors.initials: J
authors.lastname: Steier
mesh_terms: D000328:Adult; D000886:Anthropometry / Q000379:methods; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007002:Hypoglossal Nerve / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D017286:Polysomnography / Q000379:methods; D012132:Respiratory Muscles / Q000503:physiopathology; D020181:Sleep Apnea, Obstructive / Q000097:blood / Q000628:therapy*; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D010100:Oxygen
keywords: Sleep apnoea