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Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial
Cheung, Teris1,2; Lam, Joyce Yuen Ting1; Fong, Kwan Hin1; Cheng, Calvin Pak Wing3; Ho, Alex4; Sittlington, Julie5; Xiang, Yu Tao6; Li, Tim Man Ho7
2023-02-17
Source PublicationInternational journal of environmental research and public health
ISSN1660-4601
Volume20Issue:4
Abstract

Insomnia is a common health problem in the general population. There are different ways to improve sleeping habits and quality of sleep; however, there is no clinical trial using transdermal neurostimulation to treat individuals with symptoms of insomnia in Asia. This gives us the impetus to execute the first study in Asia which aims to evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. This study proposes a two-armed, double-blinded, randomized, sham-controlled trial including the active VeNS and sham VeNS group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 1-month (T3) and 3-month follow-up (T4). A total of 60 community-dwelling adults aged 18 to 60 years, with insomnia symptoms will be recruited in this study. All subjects will be computer randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. All subjects in each group will receive twenty 30-min VeNS sessions during weekdays, which will be completed in a 4-week period. Baseline measurements and post-VeNS evaluation of the psychological outcomes (i.e., insomnia severity, sleep quality and quality of life) will also be conducted on all participants. The 1-month and 3-month follow-up period will be used to assess the short-and long-term sustainability of the VeNS intervention. For statistical analysis, a mixed model will be used to analyze the repeated measures data. Missing data will be managed by multiple imputations. The level of significance will be set to p < 0.05. Significance of the study: The results of this study will be used to determine whether this VeNS device can be considered as a self-help technological device to reduce the severity of insomnia in the community setting. We registered this clinical trial with the Clinical trial government, identifier: NCT04452981.

KeywordBrain Stimulation Efficacy Insomnia Rct Vestibular Stimulation
DOI10.3390/ijerph20043577
URLView the original
Language英語English
Scopus ID2-s2.0-85148965796
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Document TypeJournal article
CollectionFaculty of Health Sciences
Affiliation1.School of Nursing, Hong Kong Polytechnic University, Hong Kong SAR, China
2.Mental Health Research Centre, Hong Kong Polytechnic University, Hong Kong SAR, China
3.Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China
4.Integrated Services for Persons with Disabilities, Christian Family Service Centre, Hong Kong SAR, China
5.Department of Biomedical Sciences, Ulster University, Londonderry, BT47 6SB, United Kingdom
6.Faculty of Health Sciences, University of Macau, Department of Public Health and Medicinal Administration, China
7.Department of Psychiatry, Chinese University of Hong Kong, Hong Kong SAR, China
Recommended Citation
GB/T 7714
Cheung, Teris,Lam, Joyce Yuen Ting,Fong, Kwan Hin,et al. Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial[J]. International journal of environmental research and public health, 2023, 20(4).
APA Cheung, Teris., Lam, Joyce Yuen Ting., Fong, Kwan Hin., Cheng, Calvin Pak Wing., Ho, Alex., Sittlington, Julie., Xiang, Yu Tao., & Li, Tim Man Ho (2023). Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial. International journal of environmental research and public health, 20(4).
MLA Cheung, Teris,et al."Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial".International journal of environmental research and public health 20.4(2023).
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