AcuSleep in Mild Traumatic Brain Injury (TBI)

Not Applicable

Completed

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, 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Arm 1: sham acupuncture	Sham Acupuncture	sham acupuncture
Arm 2: acupuncture	Acupuncture	acupuncture

Primary Outcome Measures

Name	Time	Method
PSQI Change	Baseline and post-intervention	change of global PSQI score as compared to baseline The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The PSQI global score has a possible range of 0-21 points. Any score above 5 is considered insomnia. The higher the score the worse the condition.

Secondary Outcome Measures

Name	Time	Method
Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency	pre-intervention, post-intervention (1wk of recording each)	Wrist actigraphy is a non-invasive method of continuously monitoring gross body activities when a watch-like actimetry sensor is worn at the non-dominant wrist. An algorithm has been developed to assess sleep/wake behavior. Specifically in this study, we used Respironics® actiwatches for data collection. Subjects were asked to wear the actiwatches for a consecutive week at baseline and then at post-intervention, and the actiwatches were taken off only during showers. Wrist actigraphy was examined in association with sleep diary the subjects were to keep for the weeks of monitoring. Threshold-based method algorithm for data interpretation was provided by Respironics® Actiware Software. Medium level threshold was set to detect Wake and Sleep; sleep interval detection algorithm was set for 3 minutes of immobile minutes for Sleep Onset and 5 minutes of immobile minutes for Sleep End. Sleep efficiency is sleep duration divided by total bed time (both in minutes), times 100%.