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Completed

NCT Number: NCT01862653

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

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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Overcoming Adversity and Stress and Injury Support Clinic

San Diego, California, 92106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular Acupuncture

Device

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 outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Subjects Feedback on Study

    Time frame: Week 5

    An open ended question will examine subject feedback regarding this study.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 24, 2013
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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