Sleep Disturbance in Deployed Soldiers

Sleep Disturbance Clinical Trial

Official title:

Sleep Disturbance in Deployed Soldiers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00860756
• Other study ID #: I2007.242dt
• Status: Recruiting
• Phase: Phase 0
• First received: March 10, 2009
• Last updated: March 11, 2009
• Start date: September 2007
• Est. completion date: July 2009

Study information

• Verified date: March 2009
• Source: Brooke Army Medical Center
• Contact: Mona O. Bingham, PhD
• Phone: (210) 916-7159
• Email: mona.bingham[@]amedd.army.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Hypotheses:

• Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.

• Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention group will more closely approximate normal as compared to sleep measures of Soldiers randomized to the control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• All study participants must be on Active Duty, or be Reserve or National Guard Service Members notified of impending deployment.

• Recruited prior to deployment in order to obtain baseline measures before deployment.

• Have been stateside at least one full year.

• Able to read and speak English and consent themselves.

Exclusion Criteria:

• Subjects with self-identified sleep disorder (for example restless leg syndrome or sleep apnea)

• Pregnancy. Pregnant women will be excluded from the study since pregnancy places women in a non-deployable status and pregnant Soldiers will not be deploying.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorders
• Sleep Disturbance

Intervention

Other:
• Relaxation CD
A music CD specifically created for this study to promote effective sleep while deployed. It includes sleep instructions tailored to the military deployment environment. The CD includes a voice directed meditation component that helps focus the listener on relaxation in preparation for sleep. The second track is specifically designed music to promote slow breathing and induce sleep.

Locations

Country	Name	City	State
United States	Evans Army Community Hospital	Fort Carson	Colorado
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraph and self report questionnaires		baseline, 6 months, 18 months	No
Secondary	Self report questionnaires		baseline, 6 months, 18 months	No