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AcuSleep in Mild Traumatic Brain Injury (TBI) | Clinical Trials | Clareo Health

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COMPLETEDNANCT01162317

AcuSleep in Mild Traumatic Brain Injury (TBI)

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, sha...

Lead sponsor: VA Office of Research and Development•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

VA Office of Research and Development

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 19, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment60

Start dateJul 2011

Last updatedJan 19, 2018

Condition

Brain Injuries, Traumatic Sleeplessness

Locations shown

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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