Sleep Disturbance in Deployed Soldiers

This study is currently recruiting participants.

Verified by Brooke Army Medical Center, March 2009

First Received: March 10, 2009 Last Updated: March 11, 2009 History of Changes

Sponsored by:	Brooke Army Medical Center
Information provided by:	Brooke Army Medical Center
ClinicalTrials.gov Identifier:	NCT00860756

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:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Sleep Disturbance in Deployed Soldiers

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

U.S. FDA Resources

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
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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

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
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
Carl R. Darnall Army Medical Center	Active, not recruiting
Fort Hood, Texas, United States, 76544

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:	Brooke Army Medical Center ( LTC Mona O. Bingham, PhD, RN; Chief, Nursing Research )
Study ID Numbers:	I2007.242dt
Study First Received:	March 10, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860756 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Brooke Army Medical Center:

sleep
disturbance
deployment
intervention
actigraph

Study placed in the following topic categories:

Signs and Symptoms
Mental Disorders
Neurologic Manifestations
Dyssomnias
Sleep Disorders

Additional relevant MeSH terms:

Signs and Symptoms
Mental Disorders
Nervous System Diseases

Neurologic Manifestations
Sleep Disorders
Dyssomnias

ClinicalTrials.gov processed this record on September 10, 2009