Clinical trial NCT01862653: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Sleep Disturbance
Keywords: Post Traumatic Stress Disorder
Sleep Disturbance
Acupuncture
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2013-05-24
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Objective Sleep Times
timeFrame: Baseline (upon entering study) and at one month
measure: Change in Subjective Sleep Times
timeFrame: Baseline (upon entering study) and at one month
measure: Acceptability of Acupuncture as a Treatment for Sleep Disturbance
timeFrame: One month
Secondary outcomes:
measure: Change in Sleep Quality
timeFrame: Baseline (upon entering study) and at one month
measure: Change in Sleep Quality
timeFrame: Baseline (upon entering study) and at one month
measure: Change in Depression
timeFrame: Baseline (upon entering study) and at week 3 & at week 5
measure: Change in Post Traumatic Stress Disorder Symptoms
timeFrame: Baseline (upon enterning the study) and week 3 & at week 5
Other outcomes:
measure: Subjects Feedback on Study
timeFrame: Week 5
Locations:
city: San Diego
country: United States
facility: Overcoming Adversity and Stress and Injury Support Clinic
state: California
Study officials:
affiliation: Naval Medical Center San Diego/ University of San Diego
name: Heather C King, MSN
role: PRINCIPAL_INVESTIGATOR
References: