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Sleep Disturbance in Deployed Soldiers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Brooke Army Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860756
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brooke Army Medical Center
  Purpose

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 Intervention Phase
Sleep Disturbance Other: Relaxation CD Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Sleep Disturbance in Deployed Soldiers

Resource links provided by NLM:


Further study details as provided by Brooke Army Medical Center:

Primary Outcome Measures:
  • Actigraph and self report questionnaires [ Time Frame: baseline, 6 months, 18 months ]

Secondary Outcome Measures:
  • Self report questionnaires [ Time Frame: baseline, 6 months, 18 months ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860756


Contacts
Contact: Mona O. Bingham, PhD (210) 916-7159 mona.bingham@amedd.army.mil
Contact: Stacey Young-McCaughan, PhD (210) 567-1942 stacey.young-mccaughan@us.army.mil

Locations
United States, Colorado
Evans Army Community Hospital Recruiting
Fort Carson, Colorado, United States, 80913
Contact: Mona O. Bingham, PhD    210-916-7159    mona.bingham@amedd.army.mil   
United States, Texas
Carl R. Darnall Army Medical Center Active, not recruiting
Fort Hood, Texas, United States, 76544
Brooke Army Medical Center Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Mona O. Bingham, PhD    210-916-7159    mona.bingham@amedd.army.mil   
Contact: Stacey Young-McCaughan, PhD    (210) 567-1942    stacey.young-mccaughan@us.army.mil   
Principal Investigator: Mona O Bingham, PhD         
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
Principal Investigator: Mona O. Bingham, PhD LTC, Chief Nursing Research Services
  More Information

Responsible Party: LTC Mona O. Bingham, PhD, RN; Chief, Nursing Research, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00860756     History of Changes
Other Study ID Numbers: I2007.242dt
First Submitted: March 10, 2009
First Posted: March 12, 2009
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by Brooke Army Medical Center:
sleep
disturbance
deployment
intervention
actigraph

Additional relevant MeSH terms:
Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms