Non-invasive Nerve Stimulation for PTSD and Sleep

University of Florida

Status: Enrolling

Conditions: Traumatic Brain Injury; Post Traumatic Stress Disorder

Treatments: Device: Transcutaneous nerve stimulation location 1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03170440

IRB201700541

i01 rx003140-01a (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 221 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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221 participants in 2 patient groups

Noninvasive nerve stimulation type I

Experimental group

Description:

This group will receive one type of nerve stimulation

Treatment:

Device: Transcutaneous nerve stimulation location 1

Noninvasive nerve stimulation type II

Active Comparator group

Description:

This group will receive second type of nerve stimulation

Treatment:

Device: Transcutaneous nerve stimulation location 1