Sleep DeprivationSWNCT01264913
Cardiometabolic Risk of Shiftwork
An observational study of Sleep Deprivation and Circadian Dysregulation, run by University of Chicago at 1 site in United States.
Trial summary
The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation, Circadian Dysregulation, Shift-Work Sleep Disorder
- What is being tested?
- sleep extension & circadian alignment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2015
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: We will enroll 44-46 regular day workers (work hours between 7:00 a.m. and 7:00 p.m. on all work days) and 44-46 shift workers on rotating schedules (changing shift at lease once a week and having work hours between 7:00 p.m. and 7:00 a.m. on at least 10 days per month). Both groups of subjects will work at least 30 hours per week at the University of Chicago, University of Chicago Medical Center, or other Chicago area medical center and have maintained their work schedule for at least 6 months.
Who may be able to join
- Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
- Individuals who have been shift workers for less than 10 years; body mass index <40 kg/m2;
- No major illness
- No history of psychiatric, endocrine, cardiac or sleep disorders
- Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
- Women taking oral contraceptive or hormonal replacement therapy will be included only if they plan to stay on a stable regimen throughout the study.
- Age must be between 18 and 50 years
Who cannot join
- Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
- Individuals who have been shift workers for more than 10 years
- BMI>40 kg/m2
- Individuals with a major illness (e.g. diabetes, sleep disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption
The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.
- Being tested
- sleep extension & circadian alignment
- Medical subject headings
- Sleep Deprivation, Chronobiology Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep extension & circadian alignmentBehavioural
Also called SWI intervention
Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system
| Study group | Role | What they receive |
|---|---|---|
| Shift Workers | Not described Receives: Behavioral: sleep extension & circadian alignment | |
| Day Workers | Not described Receives: Behavioral: sleep extension & circadian alignment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startAug 2009
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: impossible to retain participants in 3-year longitudinal study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264913
- Sponsor's protocol ID
- 09-049-A
- Acronym
- SW
- Status last verified
- Sep 2016
- First submitted
- 13 Dec 2010
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk of ShiftWork: Sleep Loss vs.Circadian Disruption
- ClinicalTrials.gov ID
- NCT01264913
- Acronym / sponsor ID
- SW / 09-049-A
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: impossible to retain participants in 3-year longitudinal study
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Dec 2010 (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.
The overall goal of the present application is to test the hypothesis that shift workers, who are chronically exposed to circadian misalignment and sleep loss, have a higher cardio-metabolic risk than day workers, and that the accumulated sleep debt and the degree of circadian misalignment both predict their elevated cardio-metabolic risk.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shift Workers | – | Behavioral: sleep extension & circadian alignment |
| Day Workers | – | Behavioral: sleep extension & circadian alignment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We will enroll 44-46 regular day workers (work hours between 7:00 a.m. and 7:00 p.m. on all work days) and 44-46 shift workers on rotating schedules (changing shift at lease once a week and having work hours between 7:00 p.m. and 7:00 a.m. on at least 10 days per month). Both groups of subjects will work at least 30 hours per week at the University of Chicago, University of Chicago Medical Center, or other Chicago area medical center and have maintained their work schedule for at least 6 months.
Key inclusion criteria (7 listed)
- Day workers and shift workers at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center who have maintained their work schedule (at least 30 hours/week) for at least 6 months.
- Individuals who have been shift workers for less than 10 years; body mass index <40 kg/m2;
- No major illness
- No history of psychiatric, endocrine, cardiac or sleep disorders
- Those with hypertension or dyslipidemia will be included if these conditions are controlled by a stable treatment.
Key exclusion criteria (4 listed)
- Individuals who have worked at the University of Chicago, University of Chicago Medical Center, or another Chicago area medical center in their current position for less than 6 months.
- Individuals who have been shift workers for more than 10 years
- BMI>40 kg/m2
- Individuals with a major illness (e.g. diabetes, sleep disorder)
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 |
|---|---|---|
| sleep extension & circadian alignmentAlso: SWI interventionBoth groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system | Behavioural | Day Workers, Shift Workers |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: impossible to retain participants in 3-year longitudinal study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
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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.
Eve Van Cauter principal investigator
University of Chicago
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 Deprivation and Circadian Dysregulation, run by University of Chicago 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 7 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: stopped early, as of the sponsor's last update on 3 Oct 2016. 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 was stopped early (reason given: impossible to retain participants in 3-year longitudinal study). Results are not available in the source record.
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.
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 3 Oct 2016.