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Status unknownNCT00860756Updated Mar 12, 2009

Sleep Disturbance in Deployed Soldiers

An Early Phase 1 interventional study of Relaxation CD in Sleep Disturbance, sponsored by Brooke Army Medical Center. Status unknown at 3 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by Brooke Army Medical Center · Early Phase 1 and Interventional

The sponsor has not verified this record recently (last verified Mar 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Sleep Disturbance

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Keywords

  • sleep
  • disturbance
  • deployment
  • intervention
  • actigraph
03

In context

Parasomnias

769 studies on the registry are indexed under Parasomnias; 187 are open to participants now.

This study's planned enrollment of 150 is above the median of 66 across 579 interventional studies indexed under Parasomnias.

Browse Parasomnias studies →

Lead sponsor

Brooke Army Medical Center is the lead sponsor of 94 studies on the registry; 11 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    1

    Intervention Group

    Other: Relaxation CD

Interventions

  • OtherRelaxation 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.

06

What researchers measure

Primary outcomes

  1. Actigraph and self report questionnaires

    Time frame: baseline, 6 months, 18 months

Secondary outcomes

  1. Self report questionnaires

    Time frame: baseline, 6 months, 18 months

07

Study locations

2 of 3 sites recruiting
  • Evans Army Community Hospital
    Fort Carson, Colorado 80913, United States
    Recruiting
  • Carl R. Darnall Army Medical Center
    Fort Hood, Texas 76544, United States
    Active, not recruiting
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234, United States
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Jul 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 10, 2009
First posted
Mar 12, 2009
Start
Sep 2007
Primary completionEst.
Jul 2009
CompletionEst.
Jul 2009
Last update
Mar 12, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00860756
Lead sponsor
Brooke Army Medical Center
First posted
Mar 12, 2009
Start date
Sep 2007
Primary completion
Jul 2009 (estimated)
Completion
Jul 2009 (estimated)
Last update
Mar 12, 2009

Study contacts

Mona O. Bingham, PhD
Contact
mona.bingham@amedd.army.mil
(210) 916-7159
Stacey Young-McCaughan, PhD
Contact
stacey.young-mccaughan@us.army.mil
(210) 567-1942
Mona O. Bingham, PhD
principal investigator · LTC, Chief Nursing Research Services

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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