Repeated Short Sleep ScheduleNCT01523535
Repeated Challenge of Insufficient Sleep: Endothelial Effects
A study testing repeated cycles of short sleep in people with Repeated Short Sleep Schedule, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to stay. Americans are working more and more, frequently at multiple jobs. The pattern of short sleep during the week followed by attempts to recover on the weekend is in common practice, but we know little of the associated health… Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Repeated Short Sleep Schedule
- What is being tested?
- repeated cycles of short sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2014
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Regular sleep-wake schedule
Who cannot join
- Diseases or medical conditions, including sleep disorders
- Current smoking
- Pregnant or nursing
- Recent time zone travel or shift work
- Regular medication use
- High blood pressure
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function
The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to stay. Americans are working more and more, frequently at multiple jobs. The pattern of short sleep during the week followed by attempts to recover on the weekend is in common practice, but we know little of the associated health risks. What is the cost in terms of increasing known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and is this cost compounded with repetition, without adequate recovery? Evidence is accumulating to suggest that short sleep duration is linked to the development of metabolic and inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the development of cardiovascular disease include impaired vascular function and inflammation. The current proposal is designed to investigate the effects of repeated periods of short nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep opportunity per night), and each cycle of short sleep followed by a single night of recovery sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and microcirculatory vasodilation will be assessed using perfusion imaging techniques. The dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function, will also be investigated.
Read the detailed description
Due to work, family, social and community obligations, millions of Americans cut back on sleep for several nights in a row before having an opportunity to catch up. When the opportunity does arise, it may only be for a single night, before the cycle of insufficient sleep repeats. This study investigated what happens to human biology when insufficient sleep becomes chronic and opportunities for recovery sleep are intermittent. It also investigated recovery sleep itself, and the biological processes involved in reversing the effects of an accumulated sleep deficit due to insufficient sleep duration.
- Conditions
- Repeated Short Sleep Schedule
- Being tested
- repeated cycles of short sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated cycles of short sleepBehavioural
- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| normal sleep | Placebo comparator | Subjects have 8 hours of sleep opportunity per night Receives: Behavioral: repeated cycles of short sleep |
| cycles of sleep restriction | Experimental | subjects are exposed to bouts of reduced sleep duration. The sleep loss is the intervention (experimental challenge). Receives: Behavioral: repeated cycles of short sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity
Measured: 22 days
Secondary outcomes (1)
Inflammation
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repeated Short Sleep ScheduleStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Janet M Mullington, PhD, Beth Israel Deaconess Medical Center
- Investigators
- Janet M Mullington, Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523535
- Sponsor's protocol ID
- 2010P000365
- Other IDs
- R01HL106782
- Status last verified
- Jul 2018
- First submitted
- 30 Jan 2012
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Challenge of Insufficient Sleep: Effects on Endothelial Function
- ClinicalTrials.gov ID
- NCT01523535
- Acronym / sponsor ID
- 2010P000365
- Conditions
- Repeated Short Sleep Schedule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2011 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 1 Feb 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.
The 24-hour-a-day, 7-day a week, work-world arrived within our lifetimes, and is here to stay. Americans are working more and more, frequently at multiple jobs. The pattern of short sleep during the week followed by attempts to recover on the weekend is in common practice, but we know little of the associated health risks. What is the cost in terms of increasing known risk markers for cardiovascular disease, of repeated nights of insufficient sleep, and is this cost compounded with repetition, without adequate recovery? Evidence is accumulating to suggest that short sleep duration is linked to the development of metabolic and inflammation-associated diseases, such as cardiovascular disease. Mechanisms involved in the development of cardiovascular disease include impaired vascular function and inflammation. The current proposal is designed to investigate the effects of repeated periods of short nocturnal sleep duration in 4 cycles (each cycle consisting of 3 nights of 4 hours of sleep opportunity per night), and each cycle of short sleep followed by a single night of recovery sleep. Vascular reactivity will be assessed using brachial artery flow mediated dilation, and microcirculatory vasodilation will be assessed using perfusion imaging techniques. The dependence of IL-6 and sVCAM-1 as measured in peripheral circulation, on vascular function, will also be investigated.
Detailed description
Due to work, family, social and community obligations, millions of Americans cut back on sleep for several nights in a row before having an opportunity to catch up. When the opportunity does arise, it may only be for a single night, before the cycle of insufficient sleep repeats. This study investigated what happens to human biology when insufficient sleep becomes chronic and opportunities for recovery sleep are intermittent. It also investigated recovery sleep itself, and the biological processes involved in reversing the effects of an accumulated sleep deficit due to insufficient sleep duration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal sleep | Placebo comparator | Behavioral: repeated cycles of short sleepSubjects have 8 hours of sleep opportunity per night |
| cycles of sleep restriction | Experimental | Behavioral: repeated cycles of short sleepsubjects are exposed to bouts of reduced sleep duration. The sleep loss is the intervention (experimental challenge). |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Regular sleep-wake schedule
Key exclusion criteria (6 listed)
- Diseases or medical conditions, including sleep disorders
- Current smoking
- Pregnant or nursing
- Recent time zone travel or shift work
- Regular medication use
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 |
|---|---|---|
| repeated cycles of short sleep- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles | Behavioural | cycles of sleep restriction, normal sleep |
Primary outcome
Vascular reactivity
Time frame: 22 days
1 secondary outcome
Inflammation
Time frame: 22 days
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 22 Oct 2020.
- Individual participant dataSharing planned: No
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.
Janet M Mullington, Ph.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated cycles of short sleep in people with Repeated Short Sleep Schedule, run by Beth Israel Deaconess Medical Center 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 2 inclusion and 6 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 22 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
Vascular reactivity (time frame: 22 days). 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 22 Oct 2020.