Vestibular Nerve Stimulation to Improve Sleep

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Insomnia, Sleep, Sleep Disorders, Circadian Rhythm

Intervention / Treatment
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* Device: VeNS
* Device: Placebo device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active VeNS<br>The VeSTAL device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset. | Device: VeNS<br>* Non-invasive electrical vestibular nerve stimulation<br>|
| Sham Comparator: Sham VeNS<br>The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. However, it does not deliver vestibular stimulation to users. device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day in the period immediately prior to sleep onset. | Device: Placebo device<br>* Sham non-invasive electrical vestibular nerve stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) Scores | 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. | Day 0, Day 7, Day 14, Day 21, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG Assessment | EEG power in alpha band | Day 0, Day 28 | 
| Depression Anxiety Stress Scales (DASS) Assessment | DASS will be measured during the study and will be compared to baseline readings taken prior to intervention. DASS is scored from 0 to 42 with higher scores indicating more symptoms. | Day 0, Day 7, Day 14, Day 21, Day 28 | 
| WHO Quality of Life (WHOQOL) Assessment | QOL will be measured during the study and will be compared to baseline readings taken prior to intervention. WHOQOL is scored from 0 to 100 with higher scores indicating a higher quality of life. | Day 0, Day 7, Day 14, Day 21, Day 28 |