N/A Completed N=60 Randomized Double-blind Treatment

AcuSleep in Mild Traumatic Brain Injury (TBI)

Brain Injuries, Traumatic · Sleeplessness

Source: ClinicalTrials.gov NCT01162317 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcomePrimary: PSQI Change — -2.38; -4.43 change of points from baseline

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY PSQI Change	-2.38; -4.43	—
SECONDARY Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency	73.57; 72.57; 67.94; 76.68	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01162317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.