Neuromuscular Electrical Stimulation for Obstructive Sleep Apnoea: Comparing Adherence to Active and Sham Therapy

Overview

Journal ERJ Open Res

Specialty Pulmonary Medicine

Date 2023 Dec 28

PMID 38152084

Authors

Alexandre R Abreu

Darko Stefanovski

Susheel P Patil

Trishul Siddharthan

Alejandro Chediak

Douglas M Wallace

Naresh M Punjabi

Affiliations

Soon will be listed here.

Abstract

Background: Mild obstructive sleep apnoea (OSA) is a common disorder associated with daytime sleepiness and impaired quality of life. Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed particularly for patients with mild OSA. Daytime neuromuscular electrical stimulation (NMES) of the tongue is a new therapeutic modality for mild OSA. The objective of this study was to determine if patients with mild OSA adhere to daytime NMES.

Methods: A randomised, sham-controlled, double-masked controlled trial was conducted in 40 patients with mild OSA who received either high-intensity (active) or low-intensity (sham) NMES for 6 weeks. The primary end-point was adherence to therapy. Exploratory outcomes included the respiratory event index (REI) and the Epworth Sleepiness Scale (ESS) score.

Results: More than 90% of participants in each arm were adherent to NMES. Exploratory analyses revealed a 32.7% (95% CI 15.5-49.9%) drop in the REI with active NMES, with no significant change in the REI with sham NMES. Improvements were larger in the supine than non-supine REI. Both the apnoea index and hypopnoea index improved with active NMES. Finally, the ESS score improved with active but not with sham NMES.

Conclusions: Daytime NMES was well accepted, with a majority using it for the recommended period. NMES of the tongue use was associated with improvements in OSA severity and daytime sleepiness. Additional research is needed to define its role in the treatment armamentarium across the spectrum of OSA severity and in patients who are intolerant to PAP therapy.

References

DiMatteo M, Giordani P, Lepper H, Croghan T . Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002; 40(9):794-811. DOI: 10.1097/00005650-200209000-00009. View

Sawyer A, Gooneratne N, Marcus C, Ofer D, Richards K, Weaver T . A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011; 15(6):343-56. PMC: 3202028. DOI: 10.1016/j.smrv.2011.01.003. View

Stoberl A, Schwarz E, Haile S, Turnbull C, Rossi V, Stradling J . Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017; 26(6):782-788. DOI: 10.1111/jsr.12558. View

Khan S, Duran C, Rahman H, Lekkala M, Saleem M, Kaluski E . A meta-analysis of continuous positive airway pressure therapy in prevention of cardiovascular events in patients with obstructive sleep apnoea. Eur Heart J. 2017; 39(24):2291-2297. DOI: 10.1093/eurheartj/ehx597. View

Pae E, Hyatt J, Wu J, Chien P . Short-term electrical stimulation alters tongue muscle fibre type composition. Arch Oral Biol. 2007; 52(6):544-51. DOI: 10.1016/j.archoralbio.2006.12.002. View

Kotecha B, Wong P, Zhang H, Hassaan A . A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021; 25(4):2083-2090. PMC: 8590646. DOI: 10.1007/s11325-021-02355-7. View

Nokes B, Baptista P, Ruiz de Apodaca P, Carrasco-Llatas M, Fernandez S, Kotecha B . Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep Breath. 2022; 27(2):527-534. PMC: 9701243. DOI: 10.1007/s11325-022-02644-9. View

Wimms A, Kelly J, Turnbull C, McMillan A, Craig S, OReilly J . Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial. Lancet Respir Med. 2019; 8(4):349-358. DOI: 10.1016/S2213-2600(19)30402-3. View

Roeder M, Bradicich M, Schwarz E, Thiel S, Gaisl T, Held U . Night-to-night variability of respiratory events in obstructive sleep apnoea: a systematic review and meta-analysis. Thorax. 2020; 75(12):1095-1102. DOI: 10.1136/thoraxjnl-2020-214544. View

10.

Senaratna C, Perret J, Lodge C, Lowe A, Campbell B, Matheson M . Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2016; 34:70-81. DOI: 10.1016/j.smrv.2016.07.002. View

11.

Johns M . A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991; 14(6):540-5. DOI: 10.1093/sleep/14.6.540. View

12.

Rotenberg B, Murariu D, Pang K . Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016; 45(1):43. PMC: 4992257. DOI: 10.1186/s40463-016-0156-0. View

13.

Lechat B, Naik G, Reynolds A, Aishah A, Scott H, Loffler K . Multinight Prevalence, Variability, and Diagnostic Misclassification of Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2021; 205(5):563-569. PMC: 8906484. DOI: 10.1164/rccm.202107-1761OC. View

14.

Patil S, Ayappa I, Caples S, Kimoff R, Patel S, Harrod C . Treatment of Adult Obstructive Sleep Apnea With Positive Airway Pressure: An American Academy of Sleep Medicine Systematic Review, Meta-Analysis, and GRADE Assessment. J Clin Sleep Med. 2019; 15(2):301-334. PMC: 6374080. DOI: 10.5664/jcsm.7638. View

15.

Wessolleck E, Bernd E, Dockter S, Lang S, Sama A, Stuck B . Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2019; 22(Suppl 2):47-52. PMC: 6292973. DOI: 10.1007/s11818-018-0179-z. View

16.

Engleman H, Wild M . Improving CPAP use by patients with the sleep apnoea/hypopnoea syndrome (SAHS). Sleep Med Rev. 2003; 7(1):81-99. DOI: 10.1053/smrv.2001.0197. View

17.

Jacobsen A, Eriksen F, Hansen R, Erlandsen M, Thorup L, Damgard M . Determinants for adherence to continuous positive airway pressure therapy in obstructive sleep apnea. PLoS One. 2017; 12(12):e0189614. PMC: 5734784. DOI: 10.1371/journal.pone.0189614. View

18.

Punjabi N, Patil S, Crainiceanu C, Aurora R . Variability and Misclassification of Sleep Apnea Severity Based on Multi-Night Testing. Chest. 2020; 158(1):365-373. PMC: 7339240. DOI: 10.1016/j.chest.2020.01.039. View

19.

Baptista P, Ruiz de Apodaca P, Carrasco M, Fernandez S, Wong P, Zhang H . Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea. J Clin Med. 2021; 10(9). PMC: 8123870. DOI: 10.3390/jcm10091883. View

20.

Weaver T, Grunstein R . Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008; 5(2):173-8. PMC: 2645251. DOI: 10.1513/pats.200708-119MG. View