Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
2 other identifiers
interventional
21
1 country
1
Brief Summary
The overall objectives of the proposed study are to examine the consequences of chronic circadian disruption and chronic sleep restriction on metabolic function in healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 20, 2019
August 1, 2019
5 years
June 16, 2014
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Change in insulin sensitivity
Euglycemic hyperinsulinemic clamp-assessed measure of insulin sensitivity
Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Changes in glucose levels after standardized meal
Frequent blood samples during and after standardized meal (breakfast), response of blood glucose levels
Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Change in insulin levels after standardized meal
Frequent blood samples during and after standardized meal (breakfast)
Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Change in 24h profiles of leptin
Hourly blood samples for 24 hours
Baseline day 2, during acute circadian misalignment (exposure day 3), and acute realignment (exposure day 7)
Change in 24h profiles of cortisol
Hourly blood samples for 24 hours
Baseline day 2, at 3 weeks of exposure, and 1 week into recovery
Secondary Outcomes (9)
Change in resting metabolic rate
Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Change in circadian phase and/or period
Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in sleep/wake architecture and brain electrical activity
Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Change in neurocognitive performance
Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in perception of pain, hunger and sleepiness
Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
- +4 more secondary outcomes
Study Arms (3)
Chronic circadian disruption
EXPERIMENTALFollowing a baseline of adequate time in bed, study participants will spend 3 weeks on a daily jet-lag schedule (where each day is longer than 24 hours).
Chronic sleep restriction
EXPERIMENTALFollowing a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks).
Control (sleep extension)
ACTIVE COMPARATORFollowing a baseline of adequate time in bed, study participants will continue to have adequate time in bed and opportunity for sleep during each 24-hour day, for 3 weeks.
Interventions
Following a baseline of adequate time in bed, study participants will spend 3 weeks on a daily jet-lag schedule (where each day is longer than 24 hours).
Following a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks).
Following a baseline of adequate time in bed, study participants will continue to have adequate time in bed and opportunity for sleep during each 24-hour day, for 3 weeks.
Eligibility Criteria
You may qualify if:
- Healthy adults with conventional and regular sleep-wake timing
- Non-smokers
- Completion of medical, psychological, and sleep screening tests
- Able to spend 37 consecutive days/nights in the laboratory
You may not qualify if:
- History of neurological or psychiatric disorder
- History of sleep disorder or regular use of sleep-promoting medication
- Current prescription, herbal, or over-the-counter medication use
- Traveling across 2 or more time zones within past 3 months
- Donating blood within past 8 weeks
- Worked night or rotating shift work within past 3 years
- Hearing impairment
- Drug or alcohol dependency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Xin Q, Yuan RK, Zitting KM, Wang W, Purcell SM, Vujovic N, Ronda JM, Quan SF, Williams JS, Buxton OM, Duffy JF, Czeisler CA. Impact of chronic sleep restriction on sleep continuity, sleep structure, and neurobehavioral performance. Sleep. 2022 Jul 11;45(7):zsac046. doi: 10.1093/sleep/zsac046.
PMID: 35218665DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Charles A Czeisler, PhD, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Baldino Professor of Sleep Medicine
Study Record Dates
First Submitted
June 16, 2014
First Posted
June 24, 2014
Study Start
March 31, 2014
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08