We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

AcuSleep in Mild Traumatic Brain Injury (TBI) (AcuTBI)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01162317
First Posted: July 14, 2010
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose

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 Intervention
Brain Injuries, Traumatic Sleeplessness Other: Acupuncture Other: Sham Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Novel Approaches to Sleep Difficulties: Application in Mild TBI

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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%.


Enrollment: 60
Actual Study Start Date: July 5, 2011
Estimated Study Completion Date: December 30, 2017
Primary Completion Date: September 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: sham acupuncture
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
acupuncture
Other: 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Wei Huang, MD PhD Atlanta VA Medical and Rehab Center, Decatur, GA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01162317     History of Changes
Other Study ID Numbers: B6924-W
First Submitted: June 15, 2010
First Posted: July 14, 2010
Results First Submitted: November 14, 2016
Results First Posted: April 5, 2017
Last Update Posted: August 23, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Acupuncture
Sleep
Traumatic brain injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Sleep Initiation and Maintenance Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Mental Disorders