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

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

doi:10.1007/s11325-021-02355-7

Abstract

PurposeTo 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.MethodsA 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.ResultsObjective 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.ConclusionThis 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 registrationclinicaltrials.gov identifier NCT03829956

Highlights

The spectrum of sleep-disordered breathing (SDB) encompasses disorders from primary snoring (PS) to obstructive sleep apnoea (OSA) characterised by the common pathophysiology process of repeated and recurrent collapse of the upper airway during sleep
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
Historical data traditionally states the prevalence of 4–8% of OSA in the population, literature reflects a significant increase in the prevalence over the last few decades

Summary

Introduction

The spectrum of sleep-disordered breathing (SDB) encompasses disorders from primary snoring (PS) to obstructive sleep apnoea (OSA) characterised by the common pathophysiology process of repeated and recurrent collapse of the upper airway during sleep. These repeated airway obstructions are significant as they result in recurrent nocturnal asphyxia, fragmented sleep, major fluctuations in blood pressure and increased sympathetic nervous system activity [1]. The estimated prevalence of moderate to severe OSA from the Wisconsin sleep cohort study in the USA has increased from 14 to 55% over the past

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