0396 Efficacy of electrical vestibular nerve stimulation for the management of insomnia: a randomized controlled trial

Abstract

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)