Status:
COMPLETED
AcuSleep in Mild Traumatic Brain Injury (TBI)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Brain Injuries, Traumatic
Sleeplessness
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Objective: To evaluate real acupuncture, as compare to sham acupuncture, in improving persistent sleep difficulties in veterans with mild traumatic brain injury (mTBI) Design: Randomized, blinded, sha...
Eligibility Criteria
Inclusion
- Age: 18 to 55; and,
- Meeting the diagnosis criteria for mild traumatic brain injury as listed above at the time of injury; and,
- At or over 3 months post injury; and,
- With untreated sleep complaints (Pittsburgh Sleep Quality Index \[PSQI\] \> 8, sleep difficulties at least 4x per week in the past month, average sleep duration of 6 hours or less); and,
- Has the capacity to give informed consent.
- Agree to attend 13 clinic visits
Exclusion
- Same sleep complaints present prior to traumatic brain injury; or,
- Diagnosis of obstructive sleep apnea (OSA) by prior sleep study; or,
- With a non-daytime work-schedule; or,
- With prior acupuncture experience for the treatment of sleep difficulties or with acupuncture treatment within 3 months; or,
- History of bleeding diathesis or currently on anticoagulation with international normalized ratio (INR) over 2.5; or,
- Severe depression with Beck Depression Score of 29 and above; or,
- Moderate and severe alcohol users.
- Does not have a permanent address
Key Trial Info
Start Date :
July 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01162317
Start Date
July 5 2011
End Date
December 18 2017
Last Update
January 19 2018
Active Locations (1)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033