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Non-invasive Nerve Stimulation for PTSD and Sleep

Primary Purpose

Post Traumatic Stress Disorder, Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous nerve stimulation location 1
Transcutaneous nerve stimulation location 2
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Post Traumatic Stress Disorder focused on measuring Nerve stimulation, sleep deprivation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • North Florida/South Georgia Veterans Health SystemRecruiting
  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Noninvasive nerve stimulation type I

Noninvasive nerve stimulation type II

Arm Description

This group will receive one type of nerve stimulation

This group will receive second type of nerve stimulation

Outcomes

Primary Outcome Measures

Physiological sleep architectural quality
Polysomnography

Secondary Outcome Measures

Full Information

First Posted
May 23, 2017
Last Updated
January 31, 2023
Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs, North Florida/South Georgia Veterans Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03170440
Brief Title
Non-invasive Nerve Stimulation for PTSD and Sleep
Official Title
Non-invasive Vagal Nerve Stimulation and Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
July 6, 2023 (Anticipated)
Study Completion Date
July 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
US Department of Veterans Affairs, North Florida/South Georgia Veterans Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Traumatic Brain Injury
Keywords
Nerve stimulation, sleep deprivation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
221 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Noninvasive nerve stimulation type I
Arm Type
Experimental
Arm Description
This group will receive one type of nerve stimulation
Arm Title
Noninvasive nerve stimulation type II
Arm Type
Active Comparator
Arm Description
This group will receive second type of nerve stimulation
Intervention Type
Other
Intervention Name(s)
Transcutaneous nerve stimulation location 1
Intervention Description
Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location
Intervention Type
Other
Intervention Name(s)
Transcutaneous nerve stimulation location 2
Intervention Description
Stimulation will be performed using electrodes placed in alternate location.
Primary Outcome Measure Information:
Title
Physiological sleep architectural quality
Description
Polysomnography
Time Frame
up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
De Miller-Sellers, DPT
Phone
352-317-1611
Ext
103519
Email
dolores.miller-sellers@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
John Williamson, PhD
Phone
352-376-1611
Ext
6920
Email
john.williamson2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Williamson, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De Miller-Sellers, DPT
Phone
352-376-1611
Ext
103519
Email
dolores.miller-sellers@va.gov
First Name & Middle Initial & Last Name & Degree
John Williamson, Ph.D.
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Williamson, PhD
Phone
352-294-4903
Email
john.williamson@ufl.edu
First Name & Middle Initial & Last Name & Degree
John Williamson, Ph.D.
First Name & Middle Initial & Last Name & Degree
Damon Lamb, Ph.D.
First Name & Middle Initial & Last Name & Degree
Eric Porges, Ph.D.
First Name & Middle Initial & Last Name & Degree
Michael Jaffe, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Non-invasive Nerve Stimulation for PTSD and Sleep

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