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

NCT ID: NCT01862653

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Auricular Acupuncture

An insomnia auricular acupuncture protocol will be administered for 30 minutes, three times per week, for three weeks in the intervention group.

Group Type: EXPERIMENTAL

Auricular Acupuncture

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather C King, MSN

Role: PRINCIPAL_INVESTIGATOR

Naval Medical Center San Diego/ University of San Diego

Locations

Overcoming Adversity and Stress and Injury Support Clinic

San Diego, California, United States

Countries

United States

Other Identifiers

HT9404-12-1-TS15(N12-P15)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NMCSD.2012.0053

Identifier Type: -

Identifier Source: org_study_id