AcuSleep in Mild Traumatic Brain Injury (TBI)
Completed · Not applicable · Has a placebo group
Conditions studied: Brain Injuries, Traumatic, Sleeplessness
In brief
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, sham-controlled clinical trial Setting: Outpatient clinic at a major VA medical center in Southeast USA Participants: Sixty veterans aged 24-55 (mean 40) with history of mTBI at least 3-month and beyond, suffering from sleep difficulties refractory to regular care and sleep education, as indicated by a global Pittsburgh Sleep Quality Index (PSQI) score of 14.25 + 3.23 pre-intervention (baseline). They were randomized into 2 groups, real acupuncture versus sham acupuncture, and stratified by Post-traumatic stress disorder (PTSD) diagnosed by PTSD CheckList - Military Version (PCL-M). Intervention: Real or sham acupuncture with both standardized and individualized acupoints selection. All subjects were informed that the treatments, if effective, may improve symptoms such as pain, anxiety or depression other than sleep; real acupuncture may not be effective in some individuals, and sham acupuncture may as well be effective by mind-body interactions. Outcome Measures: Primary outcome measure was global PSQI score change after intervention as compared to baseline. Secondary outcome measure was wrist-actigraphy sleep latency, sleep efficiency, wake after sleep onset (WASO), and sleep duration. PTSD was analyzed as a co-variant.
Key facts
- Study ID
- NCT01162317
- Run by
- VA Office of Research and Development
- People needed
- 60
- Starts
- 2011-07-05
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2018-01-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
Full record on ClinicalTrials.gov
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