Objectives This retrospective, open-label study was undertaken to assess the safety of repeated, long-term electrical vestibular nerve stimulation (VeNS). The primary outcome for this study was assessment of hearing function as reported by formal audiometry testing. Methods Assessments were conducted on n=25 long-term users of daily 1.5 mA VeNS. Skin inspection of the mastoid area, otoscope examination of the inner ear, and formal audiometry testing was conducted on n=18 users. All participants completed a survey-based assessment to determine usage of the device, adverse events, and long-term outcomes. Results Mean duration of use was 22 months, with approximately 80% of users reporting 1 h of daily, or 1 h of regular (2–3 times per week) VeNS usage. No adverse events were reported. There were no significant findings during examination of the mastoid areas, ear canal, or tympanic membranes. There were no significant findings reported from the formal audiogram assessments. Conclusions This appears to be the first study to provide formal assessment to show that repeated, long-term VeNS usage has not generated any significant side effects or adverse events. Results from this study further support previous literature that electrical vestibular stimulation is both safe and well-tolerated.

Introduction Insomnia is a common sleep disorder among all age groups which adversely affects physical and mental health. Young adults are considered a high-risk population group due to increased use of electronic media at bedtime, stress associated with balancing educational demands and unhealthy sleep practices. Previous research suggests that electrical vestibular nerve stimulation (VeNS) may improve sleep outcomes by influencing the hypothalamus and brainstem nuclei involved in regulating the circadian rhythm and wakefulness. The present study is a randomised, double blinded, sham-controlled trial with the aim of assessing the efficacy of VeNS on the sleep quality of young adults suffering from insomnia. Methods Eighty adults aged 18-24 years who scored 15 or higher on the Insomnia Severity Index (ISI) were recruited. Participants assigned to the intervention group (n=40) received 30 minutes per day of VeNS with 5 sessions per week for 4 weeks, while the control group (n=40) received sham stimulation for the same period. ISI scores were recorded at baseline and repeated weekly. The primary outcome was between-group change in ISI from baseline to day 28. Secondary outcomes included between-group change in the emotional states of depression, anxiety and stress measured by the DASS-21 questionnaire, and quality of life (QoL) measured by the WHOQoL-BREF. Results A group-by-time interaction effect on change in ISI score from day 0 to day 28 (F3, 248 = 295.56; P< 0.001) was observed. The intervention group had a higher reduction in mean ISI score relative to the control group at day 28 (mean change [95% CI]: 7.23 [6.78, 7.67] vs. 0.98 [0.89, 1.06], P< 0.001; respectively). Furthermore, the intervention group showed improvements in depression, anxiety, and stress scores (P< 0.001) and QoL outcomes (P< 0.001) compared with the control group. Conclusion Regular VeNS usage over 4 weeks lead to a clinically meaningful decrease in ISI scores and improved general well-being in young adults with insomnia. VeNS may have potential as a drug-free and non-invasive therapy to improve sleep outcomes. Support (if any)

Introduction Insomnia is one of the most prevalent health concerns in the general population. Cognitive behavioural therapy (CBT) and pharmacological interventions are recommended for the treatment of insomnia. However, CBT can be expensive and difficult to access, while the use of pharmacotherapy can be limited by reports of adverse events. Due to these limitations, there is a strong need for alternative measures to manage insomnia. Preliminary research indicates the potential that electrical vestibular nerve stimulation (VeNS) has as a non-invasive method for managing insomnia. The aim of this study is to evaluate the efficacy of VeNS as a method of managing sleep quantity and quality in individuals with insomnia, as compared to a sham control. Methods The study was a two-armed, double-blind randomized controlled trial that was conducted across two research sites in the United Kingdom (UK) and Hong Kong (HK). Participants aged over 18 years with an Insomnia Severity Index (ISI) score of 15 or higher were randomly assigned to intervention and control groups. The intervention group was instructed to use the VeNS device at home for 30 minutes daily for 4 weeks, while the control group was instructed to use the sham device for the same period. ISI values were captured at baseline, at 2 weeks and at 4 weeks. Sleep quality and quality of life (QoL) were assessed at baseline and at 4 weeks using the Pittsburgh Sleep Quality Index (PSQI) and the 36-item Short Form Health Survey (SF-36), respectively. Results A total of 146 participants were recruited from the HK (n=94) and UK (n=52) research sites. The study has recently been completed with the statistical analysis ongoing. The between-group change in ISI values (primary outcome), sleep quality and QoL from baseline to week 4 will be examined. Conclusion The results of this study will help determine whether the relatively inexpensive, and non-invasive technique of VeNS is effective in the management of insomnia. The data collected will be used to support regulatory submissions, primarily to the US Food and Drug Administration. Support (if any)