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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01162317
First received: June 15, 2010
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The proposed research will examine innovative and effective interventions to improve veterans' sleep and quality of life (QoL), while exploring the potential of integrating complementary alternative treatment modality, such as acupuncture, when compared to established sleep education model. The findings will also allow better understanding of the complex dimensions of sleep disturbance and its association with other co-existing symptoms (e.g. pain, depression, anxiety and post-traumatic stress [PTS]) using mild traumatic brain injury (TBI) as a model and exploration of the mechanism(s) that underlie sleep improvements.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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 Department of Veterans Affairs:

Primary Outcome Measures:
  • Sleep efficiency [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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. 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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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 (Pittsburg 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162317

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01162317     History of Changes
Other Study ID Numbers: B6924-W
Study First Received: June 15, 2010
Last Updated: January 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Acupuncture
Sleep
Traumatic brain injury

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

ClinicalTrials.gov processed this record on April 15, 2014