AcuSleep in Mild Traumatic Brain Injury (TBI)

NCT01162317 | Completed Results

• 1 other identifier: B6924-W
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injuries, Traumatic; Sleeplessness

Keywords

Acupuncture; Sleep; Traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• PSQI Change

  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.

  Baseline and post-intervention

Secondary Outcomes (1)

• Wrist Actigraphy (an Objective Sleep Measure) Sleep Efficiency

  pre-intervention, post-intervention (1wk of recording each)

Study Arms (2)

Arm 1: sham acupuncture

ACTIVE COMPARATOR

sham acupuncture

Other: Sham Acupuncture

Arm 2: acupuncture

EXPERIMENTAL

acupuncture

Other: Acupuncture

Interventions

Acupuncture OTHER

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.

Arm 2: acupuncture

Sham Acupuncture OTHER

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 1: sham acupuncture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Related Publications (1)

• Huang W, Johnson TM, Kutner NG, Halpin SN, Weiss P, Griffiths PC, Bliwise DL. Acupuncture for Treatment of Persistent Disturbed Sleep: A Randomized Clinical Trial in Veterans With Mild Traumatic Brain Injury and Posttraumatic Stress Disorder. J Clin Psychiatry. 2018 Dec 11;80(1):18m12235. doi: 10.4088/JCP.18m12235.

  PMID: 30549498 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Wei Huang (PI)
• Organization: Atlanta VAMC

wei.huang@va.gov

404-321-6111

Study Officials

• Wei Huang, MD PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: July 14, 2010
• Study Start: July 5, 2011
• Primary Completion: September 30, 2015
• Study Completion: December 18, 2017
• Last Updated: January 19, 2018
• Results First Posted: April 5, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)