Sleep Disturbance in Deployed Soldiers

Early Phase 1

• Conditions: Sleep Disturbance

• Registration Number: NCT00860756
• Lead Sponsor: Brooke Army Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2009-03
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-11
• Last Update Submitted: 2009-03-11
• Study First Posted: 2009-03-12
• Last Update Posted: 2009-03-12
• Primary Completion: 2009-07
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Actigraph and self report questionnaires	baseline, 6 months, 18 months

Secondary Outcome Measures

Name	Time	Method
Self report questionnaires	baseline, 6 months, 18 months

Trial Locations

Locations (3)

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, United States