SleepEW and EWDNCT00989534
Extended Work Schedules, Sleep Loss and Health
A study testing Fixed restricted bedtimes and Sleep restriction with circadian misalignment in people with Sleep, run by University of Chicago at 1 site in United States.
Trial summary
This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss. Read more about this study
- Who is it for?
- Ages 21 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Fixed restricted bedtimes and Sleep restriction with circadian misalignment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2009
- Phase
- Interventional
- 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 21 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
- normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
- no personal history of psychiatric or endocrine illness
- no personal history of sleep disorder, usual total sleep time of at least 7 hours
- only female volunteers with normal ovulatory cycles will be included
Who cannot join
- subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
- subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
- subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Work Schedules and Health: Role of Sleep Loss
This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.
- Conditions
- Sleep
- Being tested
- Fixed restricted bedtimes, Sleep restriction with circadian misalignment
- Keywords
- shift work, diabetes, Affects of shift work and sleep loss on health
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed restricted bedtimesBehavioural
Sleep restricted to 5 hours per night for 8 nights
Sleep restriction with circadian misalignmentBehavioural
Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep
| Study group | Role | What they receive |
|---|---|---|
| Sleep loss and circadian alignment | Experimental | Sleep restriction without circadian misalignment Receives: Behavioral: Fixed restricted bedtimes |
| Sleep loss and circadian misalignment | Experimental | Not described Receives: Behavioral: Sleep restriction with circadian misalignment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startJan 2003
- Primary completionDec 2007
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT00989534
- Sponsor's protocol ID
- 11403A
- Acronym
- EW and EWD
- Status last verified
- Sep 2016
- First submitted
- 1 Oct 2009
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.
PubMed 24458353Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.
PubMed 27271308
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
- Extended Work Schedules and Health: Role of Sleep Loss
- ClinicalTrials.gov ID
- NCT00989534
- Acronym / sponsor ID
- EW and EWD / 11403A
- Conditions
- Sleep
- Keywords
- shift work, diabetes, Affects of shift work and sleep loss on health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Oct 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.
This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep loss and circadian alignment | Experimental | Behavioral: Fixed restricted bedtimesSleep restriction without circadian misalignment |
| Sleep loss and circadian misalignment | Experimental | Behavioral: Sleep restriction with circadian misalignment |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
- normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
- no personal history of psychiatric or endocrine illness
- no personal history of sleep disorder, usual total sleep time of at least 7 hours
- only female volunteers with normal ovulatory cycles will be included
Key exclusion criteria (3 listed)
- subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
- subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
- subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
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 |
|---|---|---|
| Fixed restricted bedtimesSleep restricted to 5 hours per night for 8 nights | Behavioural | Sleep loss and circadian alignment |
| Sleep restriction with circadian misalignmentSleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep | Behavioural | Sleep loss and circadian misalignment |
Primary outcome
Not reported in the source record.
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 3 Oct 2016.
- Results publication: PubMed 24458353Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.
- Results publication: PubMed 27271308Grimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.
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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?
A study testing Fixed restricted bedtimes and Sleep restriction with circadian misalignment in people with Sleep, 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 5 inclusion and 3 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 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989534, which also lists 2 linked publications.
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.