Pilot Study to Demonstration of Safety and Efficacy of VeSTAL Sleep Device in Human Subjects: Randomized Study of VeSTAL Compared to Sham Control as a Means of Improving Sleep as Determined by ISI Scores
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Neurovalens Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Insomnia Severity Index (ISI) Scores
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings
The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both genders
- •Ages 18-24 years inclusive
- •Score above 14 in the insomnia severity index questionnaire
- •Willingness to participate in the study.
Exclusion Criteria
- •Use sleep medication
- •Ear problems
- •Under any kind of treatment
- •Practicing sleep improving techniques
- •Any other significant health-related problems.
Outcomes
Primary Outcomes
Change in Insomnia Severity Index (ISI) Scores
Time Frame: Day 0, Day 7, Day 14, Day 21, Day 28
ISI scores will be measured during the study and will be compared to baseline readings taken prior to intervention. Insomnia Severity Index scores range from 0 to 28. Scores greater than 15 indicate clinical insomnia.
Secondary Outcomes
- WHO Quality of Life (WHOQOL) Assessment(Day 0, Day 7, Day 14, Day 21, Day 28)
- EEG Assessment(Day 0, Day 28)
- Depression Anxiety Stress Scales (DASS) Assessment(Day 0, Day 7, Day 14, Day 21, Day 28)