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

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).

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep; Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Device: VeNS; Device: Placebo device

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Ujjain, Madhya Pradesh, India, 456001
      • RD Gardi Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 20 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Neurovalens Ltd.
• Collaborators: Compliance Solutions Ltd.; RD Gardi Medical College
• Investigators: Principal Investigator: Sai Sailesh, RD Gardi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: IVS001S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• 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