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Electrical Vestibular Nerve Stimulation (VeNS) as a Method of Sleep Management in People With PTSD

NCT04780893 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-01-16

No results posted yet for this study

Summary

This double blind randomized controlled study will enroll 20 subjects and will be conducted remotely. The study will be randomized for an 8-week period with a 1:1 active to sham device allocation. Primary endpoint analysis will be performed at 4 weeks.

Conditions

Interventions

DEVICE

Modius Sleep

The device utilizes a technology called vestibular nerve stimulation (VeNS). The 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 30 minutes per day.

Sponsors & Collaborators

  • Clinical Trial Mentors

    collaborator INDUSTRY

  • Neurovalens Ltd.

    lead INDUSTRY

Principal Investigators

  • David Wilson, MD · Clinical Trial Mentors

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-04-30
Completion
2022-04-30

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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 NCT04780893 on ClinicalTrials.gov