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Clinical Trials/NCT04999709
NCT04999709
Completed
N/A

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 Anxiety.

Neurovalens Ltd.1 site in 1 country74 target enrollmentJuly 11, 2022
ConditionsAnxiety

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
Neurovalens Ltd.
Enrollment
74
Locations
1
Primary Endpoint
Generalised Anxiety Disorder (GAD-7) Scores
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Anxiety is known to be one of the most common health concerns in in the general population, and the most common mental health issue, and has been associated with several health consequences. Medications are known to be effective, and currently serve as the primary treatment for anxiety but comes with a risk of adverse effects. Cognitive Behavioral Therapy (CBT-1) has also been shown to be effective and safer in the treatment of anxiety but presents its own limitations such as the time, cost, and training required. The relationship between vestibular stimulation and anxiety continues to be explored, however its usefulness in the treatment of anxiety 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 anxiety, 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. It also could present an alternative intervention for patients who are non-responsive or refuse medication. 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 anxiety.

Registry
clinicaltrials.gov
Start Date
July 11, 2022
End Date
May 25, 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

Generalised Anxiety Disorder (GAD-7) Scores

Time Frame: 4 weeks

To evaluate the effect of the VeNS device, relative to control group on participants with anxiety (range 0-21) with higher score indicating more severe anxiety.

Secondary Outcomes

  • Number of adverse events(4 weeks)
  • Quality of life using SF-36 scores(4 weeks)
  • Insomnia Severity Index (ISI) score(4 weeks)

Study Sites (1)

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