Sleep Disturbance in Deployed Soldiers
1 other identifier
interventional
150
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Sep 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 10, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedMarch 12, 2009
March 1, 2009
1.8 years
March 10, 2009
March 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actigraph and self report questionnaires
baseline, 6 months, 18 months
Secondary Outcomes (1)
Self report questionnaires
baseline, 6 months, 18 months
Study Arms (1)
1
EXPERIMENTALIntervention Group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Evans Army Community Hospital
Fort Carson, Colorado, 80913, United States
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mona O. Bingham, PhD
LTC, Chief Nursing Research Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 10, 2009
First Posted
March 12, 2009
Study Start
September 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
March 12, 2009
Record last verified: 2009-03