Shift-Work Sleep DisorderNCT02901860
Shift Work and Risk of Cardio-vascular Disease
An observational study of Shift-Work Sleep Disorder, run by University of Chicago.
Trial summary
The purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- Sleep, Dietary and Cardio-metabolic Measurements
- Type of treatment
- Pill or oral medicine
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers.
Who may be able to join
- Age 18 and older Full-time workers- working between 7:00 a.m. and 7:00 p.m. employed full time at a medical center.
- Non-traditional full-time workers- working between 7:00 a.m. and 7:00 p.m and between 7:00 p.m. and 7:00 a.m., employed full time at a medical center.
Who cannot join
- Acute illness or recent change in medication. Persons employed for less than 3 months at their current job
- -
About this study
Official title: Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study
The purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of this research are expected to increase our understanding of physiologic tolerance to non-traditional work schedules and provide the basis for the development of methods for the early detection of adverse health effects and determine coping strategies for the millions of workers with non-traditional work schedules.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- Sleep, Dietary and Cardio-metabolic Measurements
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep, Dietary and Cardio-metabolic MeasurementsOther
At home session: 2-weeks of wrist actigraphy and sleep diaries; a food diary for the three days preceding the lab session; 24-h period of ambulatory blood pressure on a non-work day for participant. Work schedules over a 4-week period will be collected and participants identified as traditional or non-traditional workers.
Subjects will begin the stay in the research unit in the evening and will remain for about 16-20 hr. Saliva samples will be taken every 30 min from admission until bedtime. Bedtime with polysomnography will be from 11:00pm to 7:00am. Questionnaires will be administered; height, weight and waist/hip circumference and bioimpedance measurement; standard 3-h oral glucose tolerance test and blood tests (CBC, electrolytes, renal, liver and thyroid function , hemoglobin A1c, SHBG levels). For individuals with diabetes only fasting blood samples will be taken.
| Study group | Role | What they receive |
|---|---|---|
| Traditional workers | Individuals who work 'traditional" work hours, i.e., 9a-5p. Receives: Other: Sleep, Dietary and Cardio-metabolic Measurements | |
| Non-traditional workers | Individuals who have work hours outside the usual daytime period Receives: Other: Sleep, Dietary and Cardio-metabolic Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardio-metabolic risk
24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test
Measured: Once
Secondary outcomes (1)
Obesity
height, weight, BMI and waist/hip circumference and bioimpedance measurement of body fat
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901860
- Sponsor's protocol ID
- 11-0725
- Status last verified
- Jun 2023
- First submitted
- 25 Jul 2016
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Shift Work on Risk of Cardiovascular Disease and Diabetes: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02901860
- Acronym / sponsor ID
- 11-0725
- Conditions
- Shift-Work Sleep Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Sep 2016 (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 purpose of this research is to test the hypothesis that those with non-traditional work schedules (e.g. shift workers) have a higher cardio-metabolic risk than those with traditional work schedules (e.g. day workers), and that both accumulated sleep debt and the degree of circadian disruption predict the elevated cardio-metabolic risk. The findings of this research are expected to increase our understanding of physiologic tolerance to non-traditional work schedules and provide the basis for the development of methods for the early detection of adverse health effects and determine coping strategies for the millions of workers with non-traditional work schedules.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional workers | – | Other: Sleep, Dietary and Cardio-metabolic MeasurementsIndividuals who work 'traditional" work hours, i.e., 9a-5p. |
| Non-traditional workers | – | Other: Sleep, Dietary and Cardio-metabolic MeasurementsIndividuals who have work hours outside the usual daytime period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers.
Key inclusion criteria (2 listed)
- Age 18 and older Full-time workers- working between 7:00 a.m. and 7:00 p.m. employed full time at a medical center.
- Non-traditional full-time workers- working between 7:00 a.m. and 7:00 p.m and between 7:00 p.m. and 7:00 a.m., employed full time at a medical center.
Key exclusion criteria (2 listed)
- Acute illness or recent change in medication. Persons employed for less than 3 months at their current job
- -
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, Dietary and Cardio-metabolic MeasurementsAt home session: 2-weeks of wrist actigraphy and sleep diaries; a food diary for the three days preceding the lab session; 24-h period of ambulatory blood pressure on a non-work day for participant. Work schedules over a 4-week period will be collected and participants identified as traditional or non-traditional workers. Subjects will begin the stay in the research unit in the evening and will remain for about 16-20 hr. Saliva samples will be taken every 30 min from admission until bedtime. Bedtime with polysomnography will be from 11:00pm to 7:00am. Questionnaires will be administered; height, weight and waist/hip circumference and bioimpedance measurement; standard 3-h oral glucose tolerance test and blood tests (CBC, electrolytes, renal, liver and thyroid function , hemoglobin A1c, SHBG levels). For individuals with diabetes only fasting blood samples will be taken. | Other | Non-traditional workers, Traditional workers |
Primary outcome
cardio-metabolic risk
Time frame: Once
24-h ambulatory blood pressure monitoring and 3-h oral glucose tolerance test
1 secondary outcome
Obesity
Time frame: Once
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 2 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shift-Work Sleep Disorder, run by University of Chicago.
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 2 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: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
cardio-metabolic risk (time frame: Once). 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 2 Jun 2023.