PTSD
Conditions
Brief summary
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
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.
Interventions
DEVICEnon-invasive nerve stimulation
Electrical stimulation will be provided via a TENS unit.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
The study is a cross-over design comparing two stimulation types. The order of stimulation is randomly assigned. Note, there is also a dosing study. Enrollment includes the dosing study (21 participants, 3 nights each). crossover enrollment = 66
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography | One night comparison | Polysomnography measures. Slow wave sleep time. Rem sleep time. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn B. Williamson, PhD
North Florida/South Georgia Veterans Health System, Gainesville, FL
Outcome results
None listed