Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT01862653|
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : October 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Sleep Disturbance||Device: Auricular Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Auricular Acupuncture
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
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.
No Intervention: Control
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.
- Change in Objective Sleep Times [ Time Frame: Baseline (upon entering study) and at one month ]Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month.
- Change in Subjective Sleep Times [ Time Frame: Baseline (upon entering study) and at one month ]Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month
- Acceptability of Acupuncture as a Treatment for Sleep Disturbance [ Time Frame: One month ]Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question.
- Change in Sleep Quality [ Time Frame: Baseline (upon entering study) and at one month ]Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline and at one month
- Change in Sleep Quality [ Time Frame: Baseline (upon entering study) and at one month ]Change in sleep quality ratings will also be measured by the consensus sleep diary sleep quality ratings at baseline and at one month.
- Change in Depression [ Time Frame: Baseline (upon entering study) and at week 3 & at week 5 ]Change in depression will be measured by Patient Health Questionnaire, version 9 (PHQ-9) scores at baseline, at week 3, and at week 5.
- Change in Post Traumatic Stress Disorder Symptoms [ Time Frame: Baseline (upon enterning the study) and week 3 & at week 5 ]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.
- Subjects Feedback on Study [ Time Frame: Week 5 ]An open ended question will examine subject feedback regarding this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862653
|United States, California|
|Overcoming Adversity and Stress and Injury Support Clinic|
|San Diego, California, United States, 92106|
|Principal Investigator:||Heather C King, MSN||Naval Medical Center San Diego/ University of San Diego|