Brain Injuries, Traumatic Clinical Trial
Official title:
Novel Approaches to Sleep Difficulties: Application in Mild TBI
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.
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