Back to resultsAcupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
Primary Purpose
Post Traumatic Stress Disorder, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auricular Acupuncture
Sponsored by
About this trial
This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture
Eligibility Criteria
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
Sites / Locations
- Overcoming Adversity and Stress and Injury Support Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Auricular Acupuncture
Control
Arm Description
An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group.
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.
Outcomes
Primary Outcome Measures
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.
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
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.
Secondary Outcome Measures
Change in Sleep Quality
Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline 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.
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.
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.
Full Information
NCT ID
NCT01862653
First Posted
May 6, 2013
Last Updated
September 30, 2014
Sponsor
United States Naval Medical Center, San Diego
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01862653
Brief Title
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
Official Title
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Sleep Disturbance
Keywords
Post Traumatic Stress Disorder, Sleep Disturbance, Acupuncture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular Acupuncture
Arm Type
Experimental
Arm Description
An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Auricular Acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Objective Sleep Times
Description
Change in sleep times will be measured by actigraphy for seven days at baseline and again for seven days at one month.
Time Frame
Baseline (upon entering study) and at one month
Title
Change in Subjective Sleep Times
Description
Change in subjective sleep times will be measured by sleep diary for one week at baseline and again for seven days at one month
Time Frame
Baseline (upon entering study) and at one month
Title
Acceptability of Acupuncture as a Treatment for Sleep Disturbance
Description
Acceptability of Acupuncture as a treatment for sleep disturbance will be measured at one month by a likert type question.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Change in Sleep Quality
Description
Change in sleep quality will be measured by Pittsburgh Sleep Quality Index Scores at baseline and at one month
Time Frame
Baseline (upon entering study) and at one month
Title
Change in Sleep Quality
Description
Change in sleep quality ratings will also be measured by the consensus sleep diary sleep quality ratings at baseline and at one month.
Time Frame
Baseline (upon entering study) and at one month
Title
Change in Depression
Description
Change in depression will be measured by Patient Health Questionnaire, version 9 (PHQ-9) scores at baseline, at week 3, and at week 5.
Time Frame
Baseline (upon entering study) and at week 3 & at week 5
Title
Change in Post Traumatic Stress Disorder Symptoms
Description
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.
Time Frame
Baseline (upon enterning the study) and week 3 & at week 5
Other Pre-specified Outcome Measures:
Title
Subjects Feedback on Study
Description
An open ended question will examine subject feedback regarding this study.
Time Frame
Week 5
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather C King, MSN
Organizational Affiliation
Naval Medical Center San Diego/ University of San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Overcoming Adversity and Stress and Injury Support Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder
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