Sleep Disturbance in Deployed Soldiers

Sponsor

Brooke Army Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00860756

Collaborator

(none)

150

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Other: Relaxation CD	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Sleep Disturbance in Deployed Soldiers

Study Start Date :

Sep 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2009

Anticipated Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intervention Group	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.

Arm

Intervention/Treatment

Experimental: 1

Intervention Group

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.

Outcome Measures

Primary Outcome Measures

Actigraph and self report questionnaires [baseline, 6 months, 18 months]

Secondary Outcome Measures

Self report questionnaires [baseline, 6 months, 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evans Army Community Hospital	Fort Carson	Colorado	United States	80913
2	Carl R. Darnall Army Medical Center	Fort Hood	Texas	United States	76544
3	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234