Vestibular Nerve Stimulation to Improve Sleep
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Active VeNS 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
Non-invasive electrical vestibular nerve stimulation
|
Sham Comparator: Sham VeNS 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
Sham non-invasive electrical vestibular nerve stimulation
|
Outcome Measures
Primary Outcome Measures
- Change in Insomnia Severity Index (ISI) Scores [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 Outcome Measures
- EEG Assessment [Day 0, Day 28]
EEG power in alpha band
- Depression Anxiety Stress Scales (DASS) Assessment [Day 0, Day 7, Day 14, Day 21, Day 28]
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.
- WHO Quality of Life (WHOQOL) Assessment [Day 0, Day 7, Day 14, Day 21, Day 28]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults
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Both genders
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Ages 18-24 years inclusive
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Score above 15 in the insomnia severity index questionnaire
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Willingness to participate in the study.
Exclusion Criteria:
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Use sleep medication
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Ear problems
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Under any kind of treatment
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Practicing sleep improving techniques
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Any other significant health-related problems.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | RD Gardi Medical College | Ujjain | Madhya Pradesh | India | 456001 |
Sponsors and Collaborators
- Neurovalens Ltd.
- RD Gardi Medical College
- Compliance Solutions Ltd.
Investigators
- Principal Investigator: Sai Sailesh, RD Gardi Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IVS001S