Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder

Naval Medical Center

Status: Completed

Conditions: Post Traumatic Stress Disorder; Sleep Disturbance

Treatments: Device: Auricular Acupuncture

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01862653

NMCSD.2012.0053

HT9404-12-1-TS15(N12-P15) (Other Grant/Funding Number)

Details and patient eligibility

About

Post traumatic stress disorder (PTSD) has emerged as a significant problem among troops returning from combat zones. A majority of these veterans will report difficulty maintaining or initiating sleep. The purpose of this research will be to conduct a prospective, randomized, wait list controlled, small scale feasibility study to examine if the use of an auricular acupuncture regimen improves quality of sleep for Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF)veterans with PTSD receiving standard PTSD treatment. Hypothesis: Objective and subjective sleep disturbances and sleep quality will be improved in OIF/OEF veterans who receive auricular acupuncture in conjunction with standard PTSD therapy or standard therapy alone.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-50 years
• Male gender
• veteran of OIF/OEF
• comorbid mental health problems such as depression, anxiety are allowed
• self-reported sleep disturbance (defined as having one or more of the following-sleep onset latency greater than 30 minutes, two or more awakenings per night, total sleep time less than six hours per night, presence of nightmares.
• sleep disturbances must have started after a deployment

Exclusion criteria

• Axis I mental disorders incompatible with active military service
• History of moderate to severe traumatic brain injury
• Sleep Apnea
• Current use of Continuous Positive Airway Pressure Devices
• Significant Co-morbid conditions (heart, lung, liver disease, etc.)
• Other treatment programs that involve cognitive processing therapy
• No concurrent use of acupuncture during study
• taking any anticoagulation medication
• essential tremors

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Auricular Acupuncture

Experimental group

Description:

An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group.

Treatment:

Device: Auricular Acupuncture

Control

No Intervention group

Description:

The control group is a wait-list control group and will be offered the auricular acupuncture intervention after the study is complete. No intervention will be performed on control group.