Non-invasive Nerve Stimulation for PTSD and Sleep

NCT ID: NCT03170440

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-10-30

Brief Summary

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In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.

Detailed Description

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Persons suffering from PTSD or mild TBI may suffer from sleep deprivation. The purpose of this study is to explore options to improve sleep quality.

Conditions

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Post Traumatic Stress Disorder Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Noninvasive nerve stimulation type I

This group will receive one type of nerve stimulation

Group Type EXPERIMENTAL

Transcutaneous nerve stimulation location 1

Intervention Type DEVICE

Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Noninvasive nerve stimulation type II

This group will receive second type of nerve stimulation

Group Type ACTIVE_COMPARATOR

Transcutaneous nerve stimulation location 1

Intervention Type DEVICE

Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Interventions

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Transcutaneous nerve stimulation location 1

Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* veterans with history of PTSD with and without history of mild TBI

Exclusion Criteria

* history of severe psychiatric illness unrelated to PTSD or TBI
* other medical conditions of severity that may impair cognition
* current illicit or prescription drug abuse
* breathing disorder requiring constant use of oxygen
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role collaborator

North Florida/South Georgia Veterans Health System

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Williamson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health Jacksonville

Gainesville, Florida, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

UF Health Jacksonville

Jacksonville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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John Williamson, PhD

Role: CONTACT

35523761611 ext. 106920

Facility Contacts

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Meghan Marotz, MS

Role: primary

904-244-9620

John Williamson, PhD

Role: backup

3523761611 ext. 106920

John Williamson, PhD

Role: primary

352-294-4903

Meghan Marotz, MS

Role: primary

904-244-9620

Other Identifiers

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i01 rx003140-01a

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

I01RX003140-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201700541

Identifier Type: -

Identifier Source: org_study_id

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