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Recruiting NCT03170440

Non-invasive Nerve Stimulation for PTSD and Sleep

No phase Interventional Post Traumatic Stress Disorder Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous nerve stimulation location 1.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder, Traumatic Brain Injury. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-invasive Vagal Nerve Stimulation and Sleep

Overview

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.

Interventions

  • Device Transcutaneous nerve stimulation location 1
    Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location

Primary outcome measures

  • Physiological sleep architectural quality [Time frame: up to 8 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

United States · 3 centers
  • UF Health Jacksonville — Gainesville
  • University of Florida — Gainesville
  • UF Health Jacksonville — Jacksonville

Identifiers

NCT: NCT03170440 · IRB201700541 · i01 rx003140-01a · I01RX003140-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗