Vestibular Nerve Stimulation to Improve Sleep

Sponsor
Neurovalens Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04219566
Collaborator
RD Gardi Medical College (Other), Compliance Solutions Ltd. (Industry)
80
1
2
29
2.8

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
  • Device: VeNS
  • Device: Placebo device
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind (Subject, Nursing staff, Co-coordinators, Outcomes Assessor and any other study staff who have contact with the subject)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Jul 31, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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

  1. EEG Assessment [Day 0, Day 28]

    EEG power in alpha band

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adults

  • Both genders

  • Ages 18-24 years inclusive

  • Score above 15 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.

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Neurovalens Ltd.
ClinicalTrials.gov Identifier:
NCT04219566
Other Study ID Numbers:
  • IVS001S
First Posted:
Jan 7, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022