AcuSleep in Mild Traumatic Brain Injury (TBI)

NCT ID: NCT01162317

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-05
• Study Completion Date: 2017-12-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1: sham acupuncture

sham acupuncture

Group Type: ACTIVE_COMPARATOR

Sham Acupuncture

Intervention Type: 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 2: acupuncture

acupuncture

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Huang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30549498 (View on PubMed)

Other Identifiers

B6924-W

Identifier Type: -

Identifier Source: org_study_id