The Modius Sleep Study

• Research type

  Research Study

• Full title

  A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation, Compared to a Sham Control For Management Of Insomnia - The Modius Sleep Study

• IRAS ID

  301555

• Contact name

  Julie Sittlington

• Contact email

  jj.sittlington@ulster.ac.uk

• Sponsor organisation

  Neurovalens

• Clinicaltrials.gov Identifier

  NCT04452981

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for insomnia but their use is limited due to the risk of adverse events. Cognitive Behavioural Therapy (CBT-I)has also been shown to be effective and safer in the treatment of insomnia but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and sleep continues to be explored, however its usefulness in the management of insomnia is still unknown. Vestibular stimulation itself has been shown to be safe across multiple populations. If vestibular stimulation is shown to be effective in the management of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-I, providing a management option that is not only safe and effective, but broadly available to the general population.

  Double blind randomized controlled trial.
  • Allocation: Randomized
  • Endpoint classification: Efficacy Study
  • Intervention Model: Parallel Assignment in 1:1 active to sham control allocation

  The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of improving sleep quantity and quality in individuals with diagnosed insomnia, as compared to a sham control.

• REC name

  Wales REC 7

• REC reference

  22/WA/0022

• Date of REC Opinion

  3 Mar 2022

• REC opinion

  Further Information Favourable Opinion