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

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Traumatic Stress Disorder, Sleep Disturbance

Intervention / Treatment
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* Device: Auricular Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular Acupuncture<br>An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group. | Device: Auricular Acupuncture<br>* Subjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Objective Sleep Times | Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month. | Baseline (upon entering study) and at one month | 
| Change in Subjective Sleep Times | Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month | Baseline (upon entering study) and at one month | 
| Acceptability of Acupuncture as a Treatment for Sleep Disturbance | Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Quality | Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline and at one month | Baseline (upon entering study) and at one month | 
| Change in Sleep Quality | Change in sleep quality ratings will also be measured by the consensus sleep diary sleep quality ratings at baseline and at one month. | Baseline (upon entering study) and at one month | 
| Change in Depression | Change in depression will be measured by Patient Health Questionnaire, version 9 (PHQ-9) scores at baseline, at week 3, and at week 5. | Baseline (upon entering study) and at week 3 & at week 5 | 
| Change in Post Traumatic Stress Disorder Symptoms | Change in Post Traumatic Stress Disorder Symptoms will be measured by the Post Traumatic Stress Disorder Checklist at baseline, at week 3, and at week 5. | Baseline (upon enterning the study) and week 3 & at week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture