SleepSleep4NCT01596101
Circadian Rhythm of Melatonin in Burns
An observational study of Sleep and Burns, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2014
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: pediatric burn patients
Who may be able to join
- 5-18 years old
Who cannot join
- anoxic brain injury
- preexisting neurological disorder
- pre-existing sleep disorder
- no informed consent or HIPAA release
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
Official title: Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn
Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute burns | Not described | |
| rehab patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep status
actigraphy, polysomnography
Measured: 48hrs
Secondary outcomes (1)
urinary melatonin
Measured: every 2 hours for 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2009
- Primary completionNov 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596101
- Sponsor's protocol ID
- 08-07-21-03
- Acronym
- Sleep4
- Status last verified
- Aug 2014
- First submitted
- 8 May 2012
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Circadian Rhythm of Melatonin on Sleep-related Disturbances Postburn
- ClinicalTrials.gov ID
- NCT01596101
- Acronym / sponsor ID
- Sleep4 / 08-07-21-03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Apr 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 May 2012 (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.
Evaluate markers and postulated effectors of the endogenous circadian pacemaker in children admitted to the burn intensive care unit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute burns | – | – |
| rehab patients | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- pediatric burn patients
Key inclusion criteria (1 listed)
- 5-18 years old
Key exclusion criteria (4 listed)
- anoxic brain injury
- preexisting neurological disorder
- pre-existing sleep disorder
- no informed consent or HIPAA release
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep status
Time frame: 48hrs
actigraphy, polysomnography
1 secondary outcome
urinary melatonin
Time frame: every 2 hours for 48 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2014.
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Healthy Adult Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Burns, run by Shriners Hospitals for Children at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep status (time frame: 48hrs). 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 Aug 2014.