Sleep Disturbance in Deployed Soldiers

March 11, 2009 updated by: Brooke Army Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Fort Carson, Colorado, United States, 80913
    • Texas
      • Fort Hood, Texas, United States, 76544
        • Active, not recruiting
        • Carl R. Darnall Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Actigraph and self report questionnaires
Time Frame: baseline, 6 months, 18 months
baseline, 6 months, 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Self report questionnaires
Time Frame: baseline, 6 months, 18 months
baseline, 6 months, 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Investigators

  • Principal Investigator: Mona O. Bingham, PhD, LTC, Chief Nursing Research Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 11, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I2007.242dt

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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