Non-invasive Nerve Stimulation and Sleep

Study Overview
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Brief Summary
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People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Detailed Description
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People often have difficulty sleeping. Reasons are many. But, difficulty falling and staying asleep are common issues. Sleep difficulties are common in disorders such as Post Traumatic Stress Disorder. Current treatments for sleep difficulties are not effective for everyone. Better treatments are needed. In this study, the investigators are testing two nerve stimulation locations that may impact brain function in such a way that sleep is improved.

Official Title
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Transcutaneous Vagal Nerve Stimulation Improvement of Sleep Quality in Veterans With PTSD With or Without History of Mild TBI

Conditions
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PTSD

Intervention / Treatment
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* Device: non-invasive nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD English fluency Exclusion Criteria: Neurological injuries or conditions aside from mTBI that may affect outcome variables and/or other variables in the study Psychiatric issues that are unlikely to be related to trauma that may affect outcomes and/or other variables in the e.g., schizophrenia Untreated sleep apnea CPAP controlled sleep apnea is okay Major uncorrected sensory deficit Current drug or alcohol abuse Drug abuse within the last two months will result in exclusion or delay Marijuana use or alcohol intoxication within 2 weeks of study will be acceptable No pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a cross-over design comparing two stimulation locations. The order of stimulation is randomly assigned.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive nerve stimulation a<br>Electrical stimulation will be delivered to a location at the ear. | Device: non-invasive nerve stimulation<br>* Electrical stimulation will be provided via a TENS unit.<br>|
| Active Comparator: non-invasive nerve stimulation b<br>Electrical stimulation will be delivered to a location at the ear. | Device: non-invasive nerve stimulation<br>* Electrical stimulation will be provided via a TENS unit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography | Polysomnography measures sleep architecture. | One night comparison |