A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing

Bhik Kotecha, Phui Yee Wong, Henry Zhang, Amro Hassaan, Bhik Kotecha, Phui Yee Wong, Henry Zhang, Amro Hassaan

Abstract

Purpose: To ascertain the usefulness of a novel intraoral neuromuscular stimulation device in treating patients with primary snoring and mild obstructive sleep apnoea (OSA). This device uses daytime awake neuromuscular electrical stimulation (NMES) as an application to induce toning of the tongue muscles.

Methods: A prospective cohort study of 70 patients with sleep-disordered breathing was conducted. Objective snoring and respiratory parameters were recorded with 2 consecutive night WatchPat sleep studies before and after treatment. The device was used for 20 min once daily for a 6-week period. Secondary outcome measures using visual analogue scale reporting of snoring by patient and Epworth Sleepiness Score (ESS) were recorded. Quality of life parameters were also noted.

Results: Objective reduction of snoring was noted on the sleep studies in 95% of participants, with an average snoring time reduction of 48%. Subjectively, the visual analogue scale reported by partners' similarly demonstrated reduction in 95% of the patients with an average reduction of 40%. In a subset of 38 patients with mild OSA, AHI reduced from 9.8 to 4.7/h (52% reduction), ODI 7.8 to 4.3/h (45% reduction), and ESS from 9.0 to 5.1. Adverse effects encountered were minimal.

Conclusion: This prospective cohort study demonstrates a notable improvement in both objective and subjective parameters of snoring and mild OSA in both simple snorers and patients with mild OSA. This device offers a safe and novel approach to reduce snoring and mild OSA by utilising intraoral neuromuscular electrical stimulation. This could be a preferred option for patients as it alleviates the need of using an oral device during sleep.

Trial registration: clinicaltrials.gov identifier NCT03829956.

Keywords: Awake neuromuscular stimulation; Intraoral device; Mild OSA; Primary snoring.

Conflict of interest statement

Professor Kotecha received sponsorship from Signifier Medical Limited for attending clinical meetings for presentations. None of the other authors have conflicts of interest to declare.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
eXciteOSA device with smartphone app
Fig. 2
Fig. 2
eXciteOSA device in situ
Fig. 3
Fig. 3
Change in AHI, ODI and ESS in subgroup of patients with mild OSA (n=38) (p<0.001)
Fig. 4
Fig. 4
Device stimulus intensity levels during the 6-week treatment period
Fig. 5
Fig. 5
Bed partner visual analogue score (VAS) before treatment, end of treatment (week 5/6) and after stopping treatment (week 7/8) (p< 0.001)

References

    1. White DP. Sleep-related breathing disorder: 2—pathophysiology of obstructive sleep apnoea. Thorax. 1995;50:797–804. doi: 10.1136/thx.50.7.797.
    1. Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, et al. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008;31(8):1071e8.
    1. Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010;122:352–360. doi: 10.1161/CIRCULATIONAHA.109.901801.
    1. Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005;353:2034–2041. doi: 10.1056/NEJMoa043104.
    1. Peppard PE, Szklo-Coxe M, Hla KM, Young T. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006;166:1709–1715. doi: 10.1001/archinte.166.16.1709.
    1. Lechner M, Breeze C, Ohayon M, Kotecha B. Snoring and breathing pauses during sleep: interview survey of a United Kingdom population sample reveals a significant increase in the rates of sleep apnoea and obesity over the last 20 years- data from the UK sleep survey. Sleep Med. 2019;54:250–256. doi: 10.1016/j.sleep.2018.08.029.
    1. Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, et al. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015;3:310e8. doi: 10.1016/S2213-2600(15)00043-0.
    1. Peppard PE, Young T, Barnet JH, et al. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013;177:1006e14. doi: 10.1093/aje/kws342.
    1. Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Repir Med. 2019;7:687–698. doi: 10.1016/S2213-2600(19)30198-5.
    1. Neelapu BC, Kharbanda OP, Sardana HK, et al. Craniofacial and upper airway morphology in adult obstructive sleep apnea patients: a systematic review and meta-analysis of cephalometric studies. Sleep Med Rev. 2017;31:79e90. doi: 10.1016/j.smrv.2016.01.007.
    1. Dempsey JA, Xie A, Patz DS, et al. Physiology in medicine: obstructive sleep apnea pathogenesis and treatment considerations beyond airway anatomy. J Appl Physiol. 2014;116:3e12.
    1. Eckert DJ, White DP, Jordan AS, et al. Defining phenotypic causes of obstructive sleep apnea. Identification of novel therapeutic targets. Am J Respir Crit Care Med. 2013;188:996e1004. doi: 10.1164/rccm.201303-0448OC.
    1. Wilkinson V, Malhotra A, Nicholas CL, et al. Discharge patterns of human genioglossus motor units during sleep onset. Sleep. 2008;31:525e33. doi: 10.1093/sleep/31.4.525.
    1. Ferguson M, Magill JC, Kotecha BT. Narrative review of contemporary treatment options in the care of patients with obstructive sleep apnoea. Ther Adv Respir Dis. 2017;11:411–423. doi: 10.1177/1753465817736263.
    1. Aarab G, Lobbezoo F, Heymans MW, Hamburger HL, Naeije M. Long-term follow-up of a randomized controlled trial of oral appliance therapy in obstructive sleep apnea. Respiration. 2011;82(2):162–168. doi: 10.1159/000324580.
    1. Virk JS, Kotecha B. Otorhinolaryngological aspects of sleep-related breathing disorders. J Thorac Dis. 2016;8:213–223. doi: 10.21037/jtd.2016.09.67.
    1. Strollo PJ, Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, Hanson RD, Padhya TA, Steward DL, Gillespie MB, Woodson BT, van de Heyning PH, Goetting MG, Vanderveken OM, Feldman N, Knaack L, Strohl KP. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014;370:139–149. doi: 10.1056/NEJMoa1308659.
    1. Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional therapy to treat obstructive sleep apnea: a systematic review and meta-analysis. Sleep. 2015;38(5):669–675. doi: 10.5665/sleep.4652.
    1. Sillen MJ1, Franssen FM, Gosker HR, et al. Metabolic and structural changes in lower-limb skeletal muscle following neuromuscular electrical stimulation: a systematic review. PLoS One. 2013;8(9):e69391. doi: 10.1371/journal.pone.0069391.
    1. Wiltfang J, Klotz S, Wiltfang J, Jordan W, Cohrs S, Engelbe W, Hajak G. First results on daytime submandibular electrostimulation of suprahyoidal muscles to prevent night-time hypopharyngeal collapse in obstructive sleep apnea syndrome. Int J Oral Maxillofac Surg. 1999;28(1):21–25. doi: 10.1016/S0901-5027(99)80670-5.
    1. Verse T, Schwalb J, Hörmann K, et al. Submental transcutaneous electrical stimulation for obstructive sleep apnea. HNO. 2003;51(12):966–970. doi: 10.1007/s00106-003-0842-x.
    1. Wessolleck E, Bernd E, Dockter S, et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie. 2018;22(Suppl 2):S47–S52. doi: 10.1007/s11818-018-0179-z.
    1. Pae EK, Hyatt JP, Wu J, et al. Short-term electrical stimulation alters tongue muscle fibre type composition. Arch Oral Biol. 2007;52(6):544–551. doi: 10.1016/j.archoralbio.2006.12.002.
    1. Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation: Journal of the International Neuromodulation Society. 2013;16(4):376–386. doi: 10.1111/j.1525-1403.2012.00514.x.
    1. Steier J, Seymor J, Rafferty GF, et al. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011;140:998–1007. doi: 10.1378/chest.10-2614.
    1. He B, Al-Sherif M, Nido M, et al. Domiciliary use of transcutaneous electrical stimulation for patients with obstructive sleep apnoea: a conceptual framework for the TELSA home programme. J Thorac Dis. 2019;11(5):2153–2164. doi: 10.21037/jtd.2019.05.04.

Source: PubMed

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