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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862653
• Other study ID #: NMCSD.2012.0053
• Secondary ID: HT9404-12-1-TS15
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: September 30, 2014
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Post Traumatic Stress Disorder
• Sleep Disorders
• Sleep Disturbance
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Overcoming Adversity and Stress and Injury Support Clinic	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjects Feedback on Study	An open ended question will examine subject feedback regarding this study.	Week 5	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No