AcuSleep in Mild Traumatic Brain Injury (TBI) (AcuTBI)
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|ClinicalTrials.gov Identifier: NCT01162317|
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : April 5, 2017
Last Update Posted : January 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic Sleeplessness||Other: Acupuncture Other: Sham Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Novel Approaches to Sleep Difficulties: Application in Mild TBI|
|Actual Study Start Date :||July 5, 2011|
|Actual Primary Completion Date :||September 30, 2015|
|Actual Study Completion Date :||December 18, 2017|
Active Comparator: Arm 1: sham acupuncture
Other: Sham Acupuncture
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.
Experimental: Arm 2: acupuncture
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.
- PSQI Change [ Time Frame: 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.
- Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency [ Time Frame: 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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162317
|United States, Georgia|
|Atlanta VA Medical and Rehab Center, Decatur, GA|
|Decatur, Georgia, United States, 30033|
|Principal Investigator:||Wei Huang, MD PhD||Atlanta VA Medical and Rehab Center, Decatur, GA|