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Vestibular Nerve Stimulation to Improve Sleep

NCT04219566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-10-21

No results posted yet for this study

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).

Conditions

  • Insomnia
  • Sleep
  • Sleep Disorders, Circadian Rhythm

Interventions

DEVICE

VeNS

Non-invasive electrical vestibular nerve stimulation

DEVICE

Placebo device

Sham non-invasive electrical vestibular nerve stimulation

Sponsors & Collaborators

  • RD Gardi Medical College

    collaborator UNKNOWN

  • Compliance Solutions Ltd.

    collaborator INDUSTRY

  • Neurovalens Ltd.

    lead INDUSTRY

Principal Investigators

  • Sai Sailesh · RD Gardi Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219566 on ClinicalTrials.gov