Vestibular Nerve Stimulation to Improve Sleep
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
1 other identifier
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
January 7, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedOctober 21, 2022
October 1, 2022
2.4 years
January 3, 2020
October 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
EEG Assessment
Day 0, Day 28
Depression Anxiety Stress Scales (DASS) Assessment
Day 0, Day 7, Day 14, Day 21, Day 28
WHO Quality of Life (WHOQOL) Assessment
Day 0, Day 7, Day 14, Day 21, Day 28
Study Arms (2)
Active VeNS
ACTIVE COMPARATORThe 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.
Sham VeNS
SHAM COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- Adults
- Both genders
- Ages 18-24 years inclusive
- Score above 14 in the insomnia severity index questionnaire
- Willingness to participate in the study.
You may not qualify if:
- Use sleep medication
- Ear problems
- Under any kind of treatment
- Practicing sleep improving techniques
- Any other significant health-related problems.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurovalens Ltd.lead
- RD Gardi Medical Collegecollaborator
- Compliance Solutions Ltd.collaborator
Study Sites (1)
RD Gardi Medical College
Ujjain, Madhya Pradesh, 456001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sai Sailesh
RD Gardi Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 7, 2020
Study Start
March 1, 2020
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
October 21, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Data will be transferred in an encrypted PDF format. Trial staff will be given direction on how to share the trial data and given access to one specific section of a controlled cloud service which is controlled via role based access. Once they have authenticated with the service and the service verifies that they have the correct role to access the system they will be directed to a single webpage within the application where they will be able to upload the encrypted PDF. This PDF is generated on the fly and is therefore not stored in another location that could become compromised. Generating the PDF on the fly means that the source data is extracted from the database, processed and delivered in the context of a single request. These data will be transferred for each subject when they complete participation in the study.