Sleep/Wake Schedule for Physiology
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how different sleep and wake schedules affect the body by monitoring participants over a 27-day inpatient period. Participants will follow either a regular or an irregular sleep/wake schedule to observe the impact on their physiology (body functions). The trial seeks healthy individuals with a BMI (body mass index) between 18.5 and 29.5 who have not recently engaged in night work, shift work, or traveled across more than two time zones. As an unphased trial, this study offers participants the opportunity to contribute to valuable research on sleep patterns and their effects on health.
Will I have to stop taking my current medications?
Yes, you will need to stop taking your current medications to participate in this trial, as the use of medications is listed as an exclusion criterion.
What prior data suggests that this sleep/wake schedule is safe?
Studies have shown that maintaining a regular sleep schedule benefits health. Research indicates that consistent bedtimes and wake-up times improve sleep quality, crucial for mental and physical well-being. No safety concerns are associated with a regular sleep schedule, as it aligns with good sleep habits.
Conversely, research on irregular sleep schedules has identified potential risks. Irregular sleep patterns have been linked to negative health effects, such as weight gain, mood changes, and an increased risk of heart problems. This suggests that irregular sleep may not be as safe as a regular schedule. However, individual differences mean results can vary.
Both sleep schedule types are under study, but more evidence supports the safety of a regular sleep routine. When considering participation in a study, it may be helpful to reflect on how these findings relate to personal sleep experiences.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how different sleep/wake schedules might affect our physiology. Unlike medications or supplements, which are common treatments for sleep-related issues, this trial focuses on adjusting the timing of sleep itself. By comparing regular and irregular sleep schedules, researchers hope to uncover how these patterns impact health, potentially offering a non-drug approach to improving sleep quality and overall well-being. This could lead to new insights into managing sleep disorders through simple lifestyle changes.
What evidence suggests that this sleep/wake schedule is effective for physiology?
Research shows that maintaining a regular sleep schedule benefits health and daily performance. Studies have found that consistent sleep patterns can boost mood, reduce anxiety, and even extend lifespan. In this trial, participants will follow either a regular or irregular sleep/wake schedule. An irregular sleep schedule may not be as beneficial, as it has been linked to poor sleep quality, disrupted body clocks, and lower grades in students. While a regular sleep/wake schedule offers significant benefits, an irregular one may not provide the same positive effects.36789
Who Is on the Research Team?
Elizabeth B Klerman, MD PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a Body Mass Index (BMI) between 18.5 and 29.5, who have not recently worked night shifts or traveled across more than two time zones. Pregnant women or those within six months post-partum, as well as anyone on medications, cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Monitoring
Participants undergo a 27-day inpatient monitoring with varied sleep-wake schedules, randomized to regular or irregular schedules
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sleep/Wake Schedule
Trial Overview
The study examines how varying sleep-wake schedules over a period of 27 days affects circadian rhythms, learning abilities, performance levels, and mood in participants. They will be randomly assigned to either a regular or irregular sleep schedule during their stay.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participant will be on a regular sleep/wake schedule
Participant will be on an irregular sleep/wake schedule
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Published Research Related to This Trial
Citations
Behavioral and psychiatric consequences of sleep-wake ...
Some evidence indicates that a deviant sleep-wake schedule might be a predisposing factor to personality disorders.
Estimated Sleep-Wake Patterns Obtained From a Large ...
When participants were divided into those with regular and irregular sleep schedules, 58.4% were found to have an irregular sleep-wake schedule.
Effects of an irregular bedtime schedule on sleep quality ...
Our findings indicated that students with a frequently irregular bedtime had poor sleep quality, even after adjusting for the sleep time. We also found negative ...
Irregular sleep/wake patterns & poorer academic performance
These findings show that irregular sleep and light exposure patterns in college students are associated with delayed circadian rhythms and lower academic ...
Irregular Sleep-Wake Rhythm - an overview
In poor sleepers with a baseline sleep efficiency of less than 50%, the intervention increased sleep time at night by about 40 minutes, reduced nighttime sleep ...
Sleep Disorder - StatPearls - NCBI Bookshelf
Sleep disorders are a group of conditions that disturb normal sleep patterns. Sleep disorders are one of the most common clinical problems encountered.
Irregular sleep and event schedules are associated with ...
Consistent associations have been reported between irregular sleep and adverse mental and physical health outcomes, including higher BMI, weight gain, affective ...
Irregular sleep-wake syndrome Information
Symptoms of sleep-wake syndrome include irregular periods of sleep and wakefulness which disrupt the normal daily sleep-wake cycle.
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bmjgroup.com
bmjgroup.com/irregular-sleep-wake-cycle-linked-to-heightened-risk-of-major-cardiovascular-events/Irregular sleep-wake cycle linked to heightened risk of ...
An irregular sleep-wake cycle is associated with a heightened risk of major cardiovascular events, such as heart attack and stroke, even for those who clock up ...
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