Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2020-03-01
2022-07-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
VeNS
Non-invasive electrical vestibular nerve stimulation
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.
Placebo device
Sham non-invasive electrical vestibular nerve stimulation
Interventions
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VeNS
Non-invasive electrical vestibular nerve stimulation
Placebo device
Sham non-invasive electrical vestibular nerve stimulation
Eligibility Criteria
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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
* Ear problems
* Under any kind of treatment
* Practicing sleep improving techniques
* Any other significant health-related problems.
18 Years
24 Years
ALL
Yes
Sponsors
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RD Gardi Medical College
UNKNOWN
Compliance Solutions Ltd.
INDUSTRY
Neurovalens Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sai Sailesh
Role: PRINCIPAL_INVESTIGATOR
RD Gardi Medical College
Locations
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RD Gardi Medical College
Ujjain, Madhya Pradesh, India
Countries
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Other Identifiers
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IVS001S
Identifier Type: -
Identifier Source: org_study_id
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