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

NCT01862653 | Completed DMC

• 2 other identifiers: NMCSD.2012.0053HT9404-12-1-TS15(N12-P15)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Sleep Disturbance

Keywords

Post Traumatic Stress Disorder; Sleep Disturbance; Acupuncture

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (4)

• Change in Sleep Quality

  Baseline (upon entering study) and at one month

• Change in Sleep Quality

  Baseline (upon entering study) and at one month

• Change in Depression

  Baseline (upon entering study) and at week 3 & at week 5

• Change in Post Traumatic Stress Disorder Symptoms

  Baseline (upon enterning the study) and week 3 & at week 5

Other Outcomes (1)

• Subjects Feedback on Study

  Week 5

Study Arms (2)

Auricular Acupuncture

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Auricular Acupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• United States Department of Defense: collaborator

Study Sites (1)

Overcoming Adversity and Stress and Injury Support Clinic

San Diego, California, 92106, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Parasomnias

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Heather C King, MSN

  Naval Medical Center San Diego/ University of San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 24, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 1, 2014

Record last verified: 2014-09

Locations

US (1)