AgingNCT02171273
Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
A study testing Circadian Disruption and Sleep Restriction in people with Aging and Sleep Restriction, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Sleep Restriction, Circadian Disruption
- What is being tested?
- Circadian Disruption and Sleep Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2014to 1 Apr 2019
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Aging, Sleep Restriction, Circadian Disruption
- Being tested
- Circadian Disruption, Sleep Restriction, Control
- Keywords
- Sleep, Aging, Metabolism, Circadian, Genetic, Alertness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian DisruptionBehavioural
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 RestrictionBehavioural
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).
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic circadian disruption | Experimental | 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). Receives: Behavioral: Circadian Disruption |
| Chronic sleep restriction | Experimental | 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). Receives: Behavioral: Sleep Restriction |
| Control (sleep extension) | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity
Euglycemic hyperinsulinemic clamp-assessed measure of insulin sensitivity
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline day 2, at 3 weeks of exposure, and 1 week into recovery
Secondary outcomes (9)
Change in resting metabolic rate
Indirect calorimetry, daily body weight, core body temperature
Measured: 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
Via measurement of core body temperature and melatonin (salivary and plasma)
Measured: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in sleep/wake architecture and brain electrical activity
Polysomnography during sleep and wake
Measured: Continuous throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Change in neurocognitive performance
Cognitive test battery presented via computer interface
Measured: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Changes in perception of pain, hunger and sleepiness
Daily questionnaires
Measured: Daily throughout the 3-day baseline, 3-week exposure, and 1-week recovery
Change in inflammatory markers and wake-time hormone levels
Measurements on fasted blood samples
Measured: 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
Blood samples collected every 4 hours for 48 hours
Measured: 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
EKG, urinary catecholamines, fasting and postprandial blood samples for cortisol, epinephrine and norepinephrine
Measured: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery
Change in nutrient absorption
Bomb calorimetry on stool samples
Measured: Daily throughout the 3-day baseline, last 3 days of the 3-week exposure, and last three days of the 1-week recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start31 Mar 2014
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
- Investigators
- Charles A Czeisler, PhD, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171273
- Sponsor's protocol ID
- 2014-P-000243
- Other IDs
- 2P01AG009975-16A1
- Status last verified
- Aug 2019
- First submitted
- 16 Jun 2014
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35218665
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
- ClinicalTrials.gov ID
- NCT02171273
- Acronym / sponsor ID
- 2014-P-000243
- Conditions
- Aging, Sleep Restriction, Circadian Disruption
- Keywords
- Sleep, Aging, Metabolism, Circadian, Genetic, Alertness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 31 Mar 2014 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 24 Jun 2014 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic circadian disruption | Experimental | Behavioral: Circadian DisruptionFollowing 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 | Experimental | Behavioral: Sleep RestrictionFollowing 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 comparator | Behavioral: ControlFollowing 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Circadian DisruptionFollowing 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). | Behavioural | Chronic circadian disruption |
| Sleep RestrictionFollowing a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks). | Behavioural | Chronic sleep restriction |
| ControlFollowing 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. | Behavioural | Control (sleep extension) |
Primary outcome
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
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
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)
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
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
9 secondary outcomes
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
Change in circadian phase and/or period
Time frame: 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
Change in neurocognitive performance
Time frame: 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
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
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
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
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
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 20 Aug 2019.
- Derived from this study: PubMed 35218665Xin 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.
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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.
Charles A Czeisler, PhD, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Disruption and Sleep Restriction in people with Aging and Sleep Restriction, run by Brigham and Women's Hospital 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 4 inclusion and 8 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 20 Aug 2019. 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. 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?
Change in insulin sensitivity (time frame: Baseline day 3, at 1 week and at 3 weeks of exposure, and 1 week into recovery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171273, which also lists 1 linked publication.
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 20 Aug 2019.