Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism

August 16, 2019 updated by: Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Chronic 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).
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).
EXPERIMENTAL: Chronic 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).
Behavioral: 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).
ACTIVE_COMPARATOR: Control (sleep extension)
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity
Time Frame: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
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
Time Frame: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
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
Time Frame: Baseline day 2, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
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
Time Frame: Baseline day 2, during acute circadian misalignment (exposure day 3), and acute realignment (exposure day 7)
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
Time Frame: Baseline day 2, at 3 weeks of exposure, and 1 week into recovery
Hourly blood samples for 24 hours
Baseline day 2, at 3 weeks of exposure, and 1 week into recovery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in resting metabolic rate
Time Frame: Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
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
Change in circadian phase and/or period
Time Frame: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Via measurement of core body temperature and melatonin (salivary and plasma)
Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in sleep/wake architecture and brain electrical activity
Time Frame: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Polysomnography during sleep and wake
Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Change in neurocognitive performance
Time Frame: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Cognitive test battery presented via computer interface
Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in perception of pain, hunger and sleepiness
Time Frame: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Daily questionnaires
Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Change in inflammatory markers and wake-time hormone levels
Time Frame: Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Measurements on fasted blood samples
Baseline days 2 and 3, daily throughout 1st and 3rd weeks of exposure, and 1 week into recovery
Changes in daily patterns of gene expression, epigenetic or proteomic markers
Time Frame: Baseline day 2, at 1 week and at 3 weeks of exposure, and 1 week into recovery
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
Changes in measures of sympathovagal balance and autonomic function
Time Frame: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
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
Change in nutrient absorption
Time Frame: Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-P-000243
  • 2P01AG009975-16A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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