Sleep Disturbance in Deployed Soldiers | NCT00860756

Studies
Sleep Disturbance in Deployed Soldiers

NCT00860756

Sponsor

Brooke Army Medical Center

Status

Unknown status

Last Update Posted

Mar 12, 2009Estimated

Enrollment

150Estimated

Phase

Early Phase 1

Conditions

Sleep Disturbance

Interventions

Relaxation CD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 11, 2009

First Posted Date

Mar 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Intervention Group	Other: Relaxation CD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxation CD	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Self report questionnaires		baseline, 6 months, 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Mona O. Bingham, PhD	LTC, Chief Nursing Research Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evans Army Community Hospital	Recruiting	Fort Carson	Colorado	80913	United States

Condition Browse Module

MeSH Terms

ID	Term
D020447	Parasomnias

Ancestor Terms

ID	Term
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided