AcuSleep in Mild Traumatic Brain Injury (TBI) (AcuTBI)
This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01162317
First received: June 15, 2010
Last updated: March 19, 2013
Last verified: March 2013
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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
Contacts
| Contact: Wei Huang, MD PhD | (404) 321-6111 ext 6670 | wei.huang@va.gov |
| Contact: Sean Halpin, MA | (404) 321-6111 ext 5141 | Sean.Halpin@va.gov |
Locations
| United States, Georgia | |
| Atlanta VA Medical and Rehab Center, Decatur | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Wei Huang, MD PhD 404-321-6111 ext 6670 wei.huang@va.gov | |
| Principal Investigator: Wei Huang, MD PhD | |
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: | March 19, 2013 |
| 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 Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013