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Clinical Trials/NCT04452981
NCT04452981
Completed
Not Applicable

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate The Efficacy of Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control For Treatment Of Insomnia.

Neurovalens Ltd.2 sites in 2 countries153 target enrollmentJune 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Neurovalens Ltd.
Enrollment
153
Locations
2
Primary Endpoint
Insomnia Severity Index (ISI) score
Status
Completed
Last Updated
2 years ago

Overview

Brief 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 Behavioral Therapy (CBT-1) 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 treatment 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 treatment of insomnia, it could serve as a safer alternative to medications. It could also require less cost, time, and training than CBT-1, providing a treatment option that is not only safe and effective, but broadly available to the general population. Consequently this trial seeks to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation as a method of improving sleep quality and quantity, as compared to a sham control, in patients newly diagnosed with insomnia.

Registry
clinicaltrials.gov
Start Date
June 15, 2022
End Date
January 3, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Neurovalens Ltd.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Insomnia Severity Index (ISI) score

Time Frame: 4 weeks

To evaluate the effect of the VeNS device, relative to control group on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.

Secondary Outcomes

  • Number of adverse events(4 weeks)
  • Quality of life using SF-36 scores(4 weeks)
  • Quality of sleep using PSQI(4 weeks)

Study Sites (2)

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