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

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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

Original languageEnglish
Pages (from-to)923-931
Number of pages9
JournalThorax
Volume71
Issue number10
Early online date19 Jul 2016
DOIs
StatePublished - 1 Oct 2016

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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

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