Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea.

INTRODUCTION: Obstructive sleep apnea (OSA) is a common disorder with major neurocognitive and cardiovascular sequelae. The treatment of symptomatic patients with mild OSA remains controversial given that adherence to positive airway pressure (PAP) has historically been suboptimal. With this notion in mind, we assessed a daily transoral neuromuscular electrical stimulation (NMES) device for individuals with mild OSA. METHODS: The sample represents a subset of participants with a baseline AHI 5-14.9 events/hour, drawn from a parent study which also included participants with primary snoring. Outcome measures for the current study included changes in apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI) and snoring levels before and after use of the NMES.  RESULTS: Among 65 participants (68% men) with median age of 49 years (range 24 to 79) and median BMI of 27.7 kg/m2 (range 20 to 34), the NMES device was used daily for 6 weeks. We observed a significant improvement in the AHI from 10.2 to 6.8 events/hour among all participants and from 10.4 to 5.0 events/h among responders. Statistically significant improvements in the ESS, PSQI, objectively measured snoring, and bed partner-reported snoring were observed. Adherence among all participants was 85%. DISCUSSION: This NMES device has the benefit of being a treatment modality of daytime therapy which confers a high level of tolerability and patient acceptance. It alleviates the need for an in situ device during sleep and leads to improvements in OSA severity, snoring, and subjective sleep metrics, potentially crucial in mild OSA. Further studies are needed to define which individuals may benefit most from the device across the wider spectrum of OSA severity and assess long-term therapeutic outcomes. 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.

Study Objectives: Evaluating daytime neuromuscular electrical training (NMES) of tongue muscles in individuals with Primary Snoring and Mild Obstructive Sleep Apnea (OSA). Methods: A multicenter prospective study was undertaken in patients with primary snoring and mild sleep apnea where daytime NMES (eXciteOSA® Signifier Medical Technologies Ltd., London W6 0LG, UK) was used for 20 min once daily for 6 weeks. Change in percentage time spent snoring was analyzed using a two-night sleep study before and after therapy. Participants and their bed partners completed sleep quality questionnaires: Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI), and the bed partners reported on the nighttime snoring using a Visual Analogue Scale (VAS). Results: Of 125 patients recruited, 115 patients completed the trial. Ninety percent of the study population had some reduction in objective snoring with the mean reduction in the study population of 41% (p < 0.001). Bed partner-reported snoring reduced significantly by 39% (p < 0.001). ESS and total PSQI scores reduced significantly (p < 0.001) as well as bed partner PSQI (p = 0.017). No serious adverse events were reported. Conclusions: Daytime NMES (eXciteOSA®) is demonstrated to be effective at reducing objective and subjective snoring. It is associated with effective improvement in patient and bed partner sleep quality and patient daytime somnolence. Both objective and subjective measures demonstrated a consistent improvement. Daytime NMES was well tolerated and had minimal transient side effects.

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

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.

The tinnitus patient information pack: usefulness in intrusive tinnitus.

PURPOSE: The purpose of this paper is to determine a tinnitus patient information pack's (TPIP) usefulness in patients suffering with tinnitus with respect to their need for further tinnitus retraining therapy (TRT) and in reducing TRT cancellations and non-attenders. DESIGN/METHODOLOGY/APPROACH: The paper consists of prospective case series in a district general hospital ENT out-patient department. FINDINGS: Patients with tinnitus-related symptoms constitute around 2 per cent of the ENT OPD workload at the West Middlesex Hospital, Chelsea & Westminster NHS Trust, London, i.e., 365 patients with intrusive tinnitus were referred by the ENT surgeon for TRT; 56/365 patients (15.3 per cent) failed to attend and 60 (16.4 per cent) cancelled their appointments. The following year, a TPIP was administered to all tinnitus sufferers, despite the affliction's intrusiveness, and told to contact the audiology department if they felt that TRT was required, which resulted in 43/233 patients (18.5 per cent) over a one-year period self-referring for TRT; 2/233 (0.9 per cent) did not attend, and 1/233 (0.4 per cent) were cancelled appointments. PRACTICAL IMPLICATIONS: The patient-focussed TPIP acts as an initial therapy for the tinnitus sufferer by providing reassurance and self-therapy. This results in patients who are less likely to seek TRT, leading to more efficient clinical resource usage (p<0.01). ORIGINALITY/VALUE: The data suggest that all tinnitus sufferers presenting to ENT clinics could be handed a TPIP and empowered with the decision whether they require further intervention.

TORS for OSA: a practice, pitfalls and literature review.

PURPOSE: Trans-oral robotic surgery (TORS) is increasingly employed in obstructive sleep apnoea (OSA) management. Objective outcomes are generally assessed through polysomnography. Pre-operative magnetic resonance imaging (MRI) can be a useful adjunct in objective upper airway assessment, in particular the tongue base, providing useful information for surgical planning and outcome assessment, though care must be taken in patient positioning during surgery. The purpose of this paper is to identify pitfalls in this process and suggest a protocol for pre-operative MRI scanning in OSA. DESIGN/METHODOLOGY/APPROACH: This study is a four-patient prospective case-series and literature review. Outcome measures include pre- and post-operative volumetric changes in the pharynx as measured on MRI and apnoea-hypopnea indices (AHI), with cure being OSA resolution or a 50 per cent reduction in AHI. FINDINGS: All patients achieved AHI reduction and/or OSA cure following TORS, despite a decrease in pharyngeal volume measurements at the tongue base level. This study and others lacked standardisation in the MRI scanning protocol, which resulted in an inability to effectively compare pre- and post-operative scans. Pitfalls were related to variation in head/tongue position, soft-tissue marker usage and assessed area boundary limits. PRACTICAL IMPLICATIONS: TORS appears to be effective in OSA management. A new protocol for patient positioning and anatomical landmarks is suggested. ORIGINALITY/VALUE: The findings could provide directly comparable data between scans and may allow correlation between tongue base volumetric changes and AHI through subsequent and historical study meta-analysis.