AcuSleep in Mild Traumatic Brain Injury (TBI)
Condition: Brain Injuries, Traumatic; Sleeplessness
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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, 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.
    


Intervention name(s): Acupuncture; Sham Acupuncture
Intervention type(s): Other; Other
Intervention description(s): Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.; Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acupuncture; Sleep; Traumatic brain injury