Clinical trial NCT01162317: AcuSleep in Mild Traumatic Brain Injury (TBI)
Official title: Novel Approaches to Sleep Difficulties: Application in Mild TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Sleeplessness
Keywords: Acupuncture
Sleep
Traumatic brain injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PSQI Change
timeFrame: Baseline and post-intervention
Secondary outcomes:
measure: Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency
timeFrame: pre-intervention, post-intervention (1wk of recording each)
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Wei Huang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang W, Johnson TM, Kutner NG, Halpin SN, Weiss P, Griffiths PC, Bliwise DL. Acupuncture for Treatment of Persistent Disturbed Sleep: A Randomized Clinical Trial in Veterans With Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. J Clin Psychiatry. 2018 Dec 11;80(1):18m12235. doi: 10.4088/JCP.18m12235.