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Completed

NCT Number: NCT04219566

Vestibular Nerve Stimulation to Improve Sleep

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).

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Key information

Conditions

Insomnia Chronobiology Disorders Dyssomnias Mental Disorders Nervous System Diseases Occupational Diseases Sleep Sleep Disorders, Circadian Rhythm Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RD Gardi Medical College

Ujjain, Madhya Pradesh, 456001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VeNS

Device

Non-invasive electrical vestibular nerve stimulation

Placebo Device

Device

Sham non-invasive electrical vestibular nerve stimulation

Primary outcomes

  1. Change in Insomnia Severity Index (ISI) Scores

    Time frame: 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 outcomes

  1. EEG Assessment

    Time frame: Day 0, Day 28

    EEG power in alpha band

  2. Depression Anxiety Stress Scales (DASS) Assessment

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Neurovalens Ltd.

Industry

Collaborators

  • Compliance Solutions Ltd.
  • RD Gardi Medical College

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2020
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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