Clinical trial NCT02171273: Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
Official title: Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Sleep Restriction
Circadian Disruption
Keywords: Sleep
Aging
Metabolism
Circadian
Genetic
Alertness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-06-24
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) when compared to young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality. An understanding of how the circadian and sleep homeostatic neurobiological processes responds to increasing homeostatic sleep pressure, and the effects of sleep restriction on metabolism at different ages, should provide information on the regulation of sleep and metabolism in aging, as well as direction for future treatments. In the present study, we will study the separate impacts of chronic sleep restriction (while minimizing circadian disruption) and chronic circadian disruption (while minimizing sleep disruption) and a poor diet on metabolism.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
measure: Changes in glucose levels after standardized meal
timeFrame: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
measure: Change in insulin levels after standardized meal
timeFrame: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
measure: Change in 24h profiles of leptin
timeFrame: Baseline day 2, during acute circadian misalignment (exposure day 3), and acute realignment (exposure day 7)
measure: Change in 24h profiles of cortisol
timeFrame: Baseline day 2, at 3 weeks of exposure, and 1 week into recovery
Secondary outcomes:
measure: Change in resting metabolic rate
timeFrame: Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
measure: Change in circadian phase and/or period
timeFrame: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
measure: Changes in sleep/wake architecture and brain electrical activity
timeFrame: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
measure: Change in neurocognitive performance
timeFrame: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
measure: Changes in perception of pain, hunger and sleepiness
timeFrame: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
measure: Change in inflammatory markers and wake-time hormone levels
timeFrame: Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
measure: Changes in daily patterns of gene expression, epigenetic or proteomic markers
timeFrame: Baseline day 2, at 1 week and at 3 weeks of exposure, and 1 week into recovery
measure: Changes in measures of sympathovagal balance and autonomic function
timeFrame: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
measure: Change in nutrient absorption
timeFrame: Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Charles A Czeisler, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.