Non-invasive Nerve Stimulation for PTSD and Sleep

November 20, 2023 updated by: University of Florida

Non-invasive Vagal Nerve Stimulation and Sleep

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • John Williamson, Ph.D.
        • Contact:
        • Sub-Investigator:
          • Damon Lamb, Ph.D.
        • Sub-Investigator:
          • Eric Porges, Ph.D.
        • Sub-Investigator:
          • Michael Jaffe, M.D.
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • North Florida/South Georgia Veterans Health System
        • Contact:
        • Principal Investigator:
          • John Williamson, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Noninvasive nerve stimulation type I
This group will receive one type of nerve stimulation
Other: Transcutaneous nerve stimulation location 1
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location
Other: Transcutaneous nerve stimulation location 2
Stimulation will be performed using electrodes placed in alternate location.
Active Comparator: Noninvasive nerve stimulation type II
This group will receive second type of nerve stimulation
Other: Transcutaneous nerve stimulation location 1
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location
Other: Transcutaneous nerve stimulation location 2
Stimulation will be performed using electrodes placed in alternate location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological sleep architectural quality
Time Frame: up to 8 hours
Polysomnography
up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

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

Investigators

  • Principal Investigator: John Williamson, Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201700541
  • i01 rx003140-01a (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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