Non-invasive Nerve Stimulation for PTSD and Sleep

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury; Post Traumatic Stress Disorder
• Interventions: Other: Transcutaneous nerve stimulation location 1; Other: Transcutaneous nerve stimulation location 2

• Registration Number: NCT03170440
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-31
• Study Start: 2017-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 221

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Noninvasive nerve stimulation type I	Transcutaneous nerve stimulation location 1	This group will receive one type of nerve stimulation
Noninvasive nerve stimulation type II	Transcutaneous nerve stimulation location 2	This group will receive second type of nerve stimulation
Noninvasive nerve stimulation type I	Transcutaneous nerve stimulation location 2	This group will receive one type of nerve stimulation
Noninvasive nerve stimulation type II	Transcutaneous nerve stimulation location 1	This group will receive second type of nerve stimulation

Primary Outcome Measures

Name	Time	Method
Physiological sleep architectural quality	up to 8 hours	Polysomnography

Trial Locations

Locations (3)

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

North Florida/South Georgia Veterans Health System; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States