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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02171273
Other study ID # 2014-P-000243
Secondary ID 2P01AG009975-16A
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2014
Est. completion date April 1, 2019

Study information

Verified date August 2019
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Circadian Disruption
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).
Sleep Restriction
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).
Control
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.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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)
Primary 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 Change in resting metabolic rate Indirect calorimetry, daily body weight, core body temperature Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Secondary Change in circadian phase and/or period Via measurement of core body temperature and melatonin (salivary and plasma) Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary Changes in sleep/wake architecture and brain electrical activity Polysomnography during sleep and wake Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary Change in neurocognitive performance Cognitive test battery presented via computer interface Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary Changes in perception of pain, hunger and sleepiness Daily questionnaires Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Secondary Change in inflammatory markers and wake-time hormone levels Measurements on fasted blood samples Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Secondary Changes in daily patterns of gene expression, epigenetic or proteomic markers Blood samples collected every 4 hours for 48 hours Baseline day 2, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Secondary Changes in measures of sympathovagal balance and autonomic function EKG, urinary catecholamines, fasting and postprandial blood samples for cortisol, epinephrine and norepinephrine Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Secondary Change in nutrient absorption Bomb calorimetry on stool samples Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery
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