Status:
RECRUITING
Non-invasive Nerve Stimulation and Sleep
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Eligibility:
All Genders
18-55 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- Condition: Hx VA/DOD criteria PTSD w or w/o mTBI and current sig symptoms of PTSD
- English fluency
Exclusion
- 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
Key Trial Info
Start Date :
January 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04021537
Start Date
January 30 2020
End Date
November 29 2025
Last Update
May 13 2025
Active Locations (1)
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1
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135