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NCT Number: NCT03170440

Non-invasive Nerve Stimulation for PTSD and Sleep

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

Recruiting

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Key information

Conditions

Post Traumatic Stress Disorder Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Jacksonville, Gainesville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

with:

  • 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

Treatment and study plan

Transcutaneous nerve stimulation location 1

Device

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

Primary outcomes

  1. Physiological sleep architectural quality

    Time frame: up to 8 hours

    Polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

John Williamson, PhD

CONTACT

[email protected]

35523761611 ext. 106920

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • North Florida/South Georgia Veterans Health System
  • US Department of Veterans Affairs

Registry information

Official study title

Non-invasive Vagal Nerve Stimulation and Sleep

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 31, 2017
Registry last updated
Jul 1, 2025

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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