Sleep Disturbance in Deployed Soldiers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Brooke Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brooke Army Medical Center
ClinicalTrials.gov Identifier:
NCT00860756
First received: March 10, 2009
Last updated: March 11, 2009
Last verified: March 2009
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self report questionnaires [ Time Frame: baseline, 6 months, 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 10, 2009
Last Updated: March 11, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on July 24, 2014