Sleep DisturbanceEarly Phase 1NCT00860756
Sleep Disturbance in Deployed Soldiers
A Early Phase 1 study testing Relaxation CD in people with Sleep Disturbance, run by Brooke Army Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Relaxation CD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Jul 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Recruiting
Evans Army Community Hospital
Fort Carson, Colorado, 80913
Mona O. Bingham, PhD, 210-916-7159, mona.bingham@amedd.army.mil
- Active, not recruiting
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Mona O. Bingham, PhD, 210-916-7159, mona.bingham@amedd.army.mil
Stacey Young-McCaughan, PhD, (210) 567-1942, stacey.young-mccaughan@us.army.mil
About this study
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.
- Conditions
- Sleep Disturbance
- Being tested
- Relaxation CD
- Keywords
- sleep, disturbance, deployment, intervention, actigraph
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation CDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention Group Receives: Other: Relaxation CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraph and self report questionnaires
Measured: baseline, 6 months, 18 months
Secondary outcomes (1)
Self report questionnaires
Measured: baseline, 6 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startSep 2007
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Mona O. Bingham, PhD, Principal investigator, LTC, Chief Nursing Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860756
- Sponsor's protocol ID
- I2007.242dt
- Status last verified
- Mar 2009
- First submitted
- 10 Mar 2009
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance in Deployed Soldiers
- ClinicalTrials.gov ID
- NCT00860756
- Acronym / sponsor ID
- I2007.242dt
- Conditions
- Sleep Disturbance
- Keywords
- sleep, disturbance, deployment, intervention, actigraph
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Sep 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Relaxation CDIntervention Group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation CDA 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. | Other | 1 |
Primary outcome
Actigraph and self report questionnaires
Time frame: baseline, 6 months, 18 months
1 secondary outcome
Self report questionnaires
Time frame: baseline, 6 months, 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona O. Bingham, PhD principal investigator
LTC, Chief Nursing Research Services
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Relaxation CD in people with Sleep Disturbance, run by Brooke Army Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona O. Bingham, PhD ((210) 916-7159, mona.bingham@amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraph and self report questionnaires (time frame: baseline, 6 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2009.