Non-invasive Nerve Stimulation and Sleep
Purpose
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.
Condition
- PTSD
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental non-invasive nerve stimulation a |
Electrical stimulation will be delivered to a location at the ear. |
|
|
Sham Comparator non-invasive nerve stimulation b |
Electrical stimulation will be delivered to a location at the ear for two minutes and rolled off to zero slowly. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
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. Prior to the cross-over study described here, a dosing study will be completed. Twenty Veterans with PTSD with or without history of mTBI, assessed for inclusion and exclusion per protocol, will be evaluated over three polysomnography nights with at least a one week washout period. Pseudo-randomly distributed across the three nights, each participant will be tested on three of the 10 parameters, creating a total of 60 testing sessions (6 for each parameter setting with each represented twice in each night slot). primary sleep architecture variables (slow wave sleep time, REM sleep time) and autonomic responses will be used as outcomes. The optimal dose will be selected and the study will proceed to the cross-over design phase.
