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Original research
Randomised, controlled crossover trial of intermittent and continuous transcutaneous electrical stimulation of the genioglossus muscle for obstructive sleep apnoea
  1. Xiaofeng Wu1,
  2. Dong Zhao1,
  3. Weihua Hu2,
  4. Zhishui Zheng1,
  5. Shiqian Zha1,
  6. Qingfeng Zhang1,
  7. Ke Hu1
  1. 1Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, Hubei, China
  2. 2Department of Pediatrics, Renmin Hospital of Wuhan University, Wuhan, Hubei, China
  1. Correspondence to Dr Ke Hu, Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China; huke-rmhospital{at}163.com

Abstract

Purpose Continuous transcutaneous electrical stimulation (CTES) of the genioglossus muscle may benefit patients with obstructive sleep apnoea (OSA). However, the therapeutic value of intermittent transcutaneous electrical stimulation (ITES) for OSA is unclear.

Methods This was a randomised, controlled, crossover study to compare the effects of ITES and CTES of the genioglossus muscle. Over three single-night sessions, participants were alternately subjected to three genioglossus stimulation modalities during sleep (sham, CTES and ITES). The apnoea-hypopnoea index (AHI) and oxygen desaturation index (ODI) were used for OSA diagnosis and to evaluate efficacy. A responder was defined as an individual with a ≥50% reduction in AHI together with <10 AHI events per hour and/or an ODI reduction of ≥25% between sham stimulation and electrical stimulation nights.

Results Fifteen men with OSA completed the study. Compared with sham, the median AHI with ITES decreased by 13.3 events/hour (95% CI 3.1 to 23.5, p=0.030) and by 7.3 events/hour (95% CI −3.9 to 18.5, p=0.825) with CTES. The median ODI was reduced by 9.25 events/hour (95% CI 0.5 to 18.0) with ITES and 3.3 events/hour (95% CI −5.6 to 12.2) with CTES; however, there was no significant difference between groups. Furthermore, ITES outperformed CTES with respect to longest apnoea duration (median (95% CI), 9.5 (0.0 to 19.0), p=0.011)) and the highest sleep efficiency (12.2 (2.7 to 21.7), p=0.009). Of the 15 participants, 8 responded to ITES and 3 responded to CTES (p=0.058), of whom all eight cases and two out of three cases had ODIs <5 events/hour, respectively. All participants tolerated ITES well.

Conclusions ITES improved upper airway obstruction in patients with OSA, suggesting that further prospective validation of the intermittent approach is warranted.

Trial registration number ChiCTR2100050138.

  • Sleep apnoea

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • XW and DZ contributed equally.

  • Contributors KH: study conception and design; data analysis and interpretation; drafting the manuscript and final approval; obtaining funding. XW and DZ: study design; data acquisition, analysis and interpretation; drafting the manuscript and final approval. XW and DZ: statistical analysis. ZZ and DZ: drug-induced sleep endoscopy. WH, ZZ, SZ and QZ: recruiting participants, clinical diagnosis and data collection.KH is responsible for the overall content as the guarantor

  • Funding This research was supported by grant from the National Natural Science Foundation of China (No. 81970082).

  • Disclaimer The sponsors had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and the decision to submit the manuscript for publication.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.