AcuSleep in Mild Traumatic Brain Injury (TBI)
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Hospital, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/21/2018 |
| Start Date: | July 5, 2011 |
| End Date: | December 18, 2017 |
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.
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.
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
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