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; Gian Paolo Rossi; Adrian Williams; Michael I. Polkey; John Moxham; Joerg Steier

doi:10.1136/thoraxjnl-2016-208691

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, Gian Paolo Rossi, Adrian Williams, Michael I. Polkey, John Moxham, Joerg Steier^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

45 Citations (Scopus)

455 Downloads (Pure)

Abstract

Introduction: 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.

Patients and 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 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

Original language	English
Pages (from-to)	923-931
Number of pages	9
Journal	Thorax
Volume	71
Issue number	10
Early online date	19 Jul 2016
DOIs	https://doi.org/10.1136/thoraxjnl-2016-208691
Publication status	Published - 1 Oct 2016

Access to Document

10.1136/thoraxjnl-2016-208691Licence: CC BY

Randomised sham-controlled trial_PENGO_Accepted23June2016_GOLD VoRFinal published version, 612 KBLicence: CC BY

Cite this

@article{64996bc384544a9abed177c1cc5a7f0e,

title = "Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea",

abstract = "Introduction: 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. Patients and 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 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",

author = "Pengo, {Martino F.} and Sichang Xiao and Culadeeban Ratneswaran and Kate Reed and Nimish Shah and Tao Chen and Abdel Douiri and Nicholas Hart and Yuanming Luo and Rafferty, {Gerrard F.} and Rossi, {Gian Paolo} and Adrian Williams and Polkey, {Michael I.} and John Moxham and Joerg Steier",

note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/",

year = "2016",

month = oct,

day = "1",

doi = "10.1136/thoraxjnl-2016-208691",

language = "English",

volume = "71",

pages = "923--931",

journal = "Thorax",

issn = "0040-6376",

publisher = "BRITISH MED JOURNAL PUBL GROUP",

number = "10",

}

TY - JOUR

T1 - Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea

AU - Pengo, Martino F.

AU - Xiao, Sichang

AU - Ratneswaran, Culadeeban

AU - Reed, Kate

AU - Shah, Nimish

AU - Chen, Tao

AU - Douiri, Abdel

AU - Hart, Nicholas

AU - Luo, Yuanming

AU - Rafferty, Gerrard F.

AU - Rossi, Gian Paolo

AU - Williams, Adrian

AU - Polkey, Michael I.

AU - Moxham, John

AU - Steier, Joerg

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Introduction: 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. Patients and 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 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

AB - Introduction: 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. Patients and 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 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

UR - http://www.scopus.com/inward/record.url?scp=85009808162&partnerID=8YFLogxK

U2 - 10.1136/thoraxjnl-2016-208691

DO - 10.1136/thoraxjnl-2016-208691

M3 - Article

C2 - 27435610

SN - 0040-6376

VL - 71

SP - 923

EP - 931

JO - Thorax

JF - Thorax

IS - 10

ER -

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

Abstract

Access to Document

Other files and links

Fingerprint

Cite this