Trial record 16 of 1847 for:    Parasomnias

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by United States Naval Medical Center, San Diego
Sponsor:
Collaborator:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01862653
First received: May 6, 2013
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Post Traumatic Stress Disorder
Sleep Disturbance
Device: Auricular Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acupuncture for Sleep Disturbances in OEF/OIF Veterans With Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Change in Objective Sleep Times [ Time Frame: Baseline (upon entering study) and at one month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (upon entering study) and at one month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Subjects Feedback on Study [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    An open ended question will examine subject feedback regarding this study.


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862653

Contacts
Contact: Heather C King, MSN 619-788-6728 heather.king@med.navy.mil

Locations
United States, California
Overcoming Adversity and Stress and Injury Support Clinic Recruiting
San Diego, California, United States, 92106
Contact: kenneth Richter, MD    619-524-9605    kenneth.richter@med.navy.mil   
Sub-Investigator: Ronald Elesh, MD         
Sub-Investigator: Paul Sargent, MD         
Sub-Investigator: Anita Hickey, MD         
Sub-Investigator: Dennis Spence, PhD         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Heather C King, MSN Naval Medical Center San Diego/ University of San Diego
  More Information

No publications provided

Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01862653     History of Changes
Other Study ID Numbers: NMCSD.2012.0053, HT9404-12-1-TS15(N12-P15)
Study First Received: May 6, 2013
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
Post Traumatic Stress Disorder
Sleep Disturbance
Acupuncture

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on July 28, 2014