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

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

Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea

“…Bipolar biphasic current was delivered with predetermined stimulation and rest periods, migrating between three low frequencies (0 to 20 Hz). The intensity of therapy (maximum of 15 mV) was controlled by the patient and they were advised to use the maximal tolerable intensity without discomfort [23]. The smartphone app was used to start and stop the device which was set to 20 min therapy.…”

“…This clinical trial was designed to expand the clinical findings of a previous study that was published recently that demonstrated a notable improvement in simple snorers and patients with mild OSA [23]. The aim of this multicenter trial was to substantiate both objective and subjective outcomes of the transoral NMES in a larger cohort, evaluate change in sleep study parameters, evaluate tolerability, and observe outcomes related sleep quality and daytime somnolence.…”

Current and novel treatment options for obstructive sleep apnoea

“…In a double-blind, randomised and placebo-controlled study of 67 patients, using 20 min of stimulation over 8 weeks, snoring, but not the AHI, improved with intervention [ 155 ]. In addition, the method was tested in two separate reports of the same registered clinical trial, firstly, in 70 patients [ 156 ], and secondly in 125 patients [ 157 ] with snoring and mild OSA for 20 min (once daily) over a 6-week period. It was confirmed that snoring improved [ 156 ] while there was a modest improvement in the AHI in a subgroup [ 156 ].…”

Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

“…Die folgende prospektive multizentrische Studie [37], deren 115 Patienten zu 56 % aus Betroffenen mit leichtgradiger OSA und zu 44 % aus Schnarchern mit einem AHI < 5/h bestand, zeigte ebenfalls wieder einen signifikanten Anstieg der schlafbezogenen Lebensqualität in beiden Gruppen: Die unter Therapie befindlichen Schnarchern verringerten den PSQI von 7,2 auf 5,8 Punkte (p < 0,001) und die Bettpartner von 6,9 auf 5,9 (p < 0,02). Analog zur vorherigen Arbeit [36] war auch hier die Tagesschläfrigkeit im ESS beim Schnarcher (8,4 auf 5,8 Punkte, p < 0,01) klar gebessert, während die Veränderung beim Bettpartner keine statistische Relevanz erreichte (6,2 auf 5,7 Punkte, p = 0,22). Ein hoher ESS-Ausgangswert korrelierte gut mit einem Therapieansprechen hinsichtlich der objektivierbaren Laustärke des Schnarchens.…”

“…Dabei war die Trainingscompliance mit durchschnittlich 83% 37 bzw. 83,3% 36 hoch, wobei die Spanne für letztere Kohorte mit 59,5 bis 95,2% angegeben wird.…”