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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01162317
First received: June 15, 2010
Last updated: February 17, 2017
Last verified: February 2017
Results First Received: November 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Brain Injuries, Traumatic
Sleeplessness
Interventions: Other: Acupuncture
Other: Sham Acupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1: Sham Acupuncture

sham acupuncture

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.

Arm 2: Acupuncture

acupuncture

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.


Participant Flow:   Overall Study
    Arm 1: Sham Acupuncture   Arm 2: Acupuncture
STARTED   30   30 
COMPLETED   27   28 
NOT COMPLETED   3   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1: Sham Acupuncture

sham acupuncture

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.

Arm 2: Acupuncture

acupuncture

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.

Total Total of all reporting groups

Baseline Measures
   Arm 1: Sham Acupuncture   Arm 2: Acupuncture   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      30 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 40  (10.3)   39.6  (9.7)   39.8  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  26.7%      6  20.0%      14  23.3% 
Male      22  73.3%      24  80.0%      46  76.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   30   30   60 
Pittsburgh Sleep Quality Index (PSQI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.33  (3.10)   14.17  (3.41)   14.26  (3.20) 
[1] In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. Only global PSQI scores were used for this study.


  Outcome Measures
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1.  Primary:   PSQI Change   [ Time Frame: Baseline and post-intervention ]

2.  Secondary:   Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency   [ Time Frame: pre-intervention, post-intervention (1wk of recording each) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wei Huang (PI)
Organization: Atlanta VAMC
phone: 404-321-6111 ext 6517
e-mail: wei.huang@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01162317     History of Changes
Other Study ID Numbers: B6924-W
Study First Received: June 15, 2010
Results First Received: November 14, 2016
Last Updated: February 17, 2017