Sleep/Wake Schedule for Physiology

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

EB

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

You do not have any medical conditions or illnesses.
Your body mass index (BMI) falls within a healthy range, which is between 18.5 and 29.5.

Exclusion Criteria

recent night-work, shift-work, or travel across >2 time zones
pregnant or within 6 months post-partum
I'm sorry, but "medications" is not a criterion. Can you please provide more information or context?
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Monitoring

Participants undergo a 27-day inpatient monitoring with varied sleep-wake schedules, randomized to regular or irregular schedules

27 days
Daily inpatient monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?
2Treatment groups
Experimental Treatment
Group I: Regular ScheduleExperimental Treatment1 Intervention
Group II: Irregular ScheduleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Published Research Related to This Trial

Implementing a Sleep Program in the surgical intensive care unit significantly improved patient satisfaction with sleep by 28 percentage points, highlighting the importance of a healing environment for hospitalized patients.
The project focused on changing sleep management practices based on evidence-based approaches, which can lead to better healing and reduced stress for stable patients.
Promoting sleep in the adult surgical intensive care unit patients to prevent delirium.Hata, RK., Han, L., Slade, J., et al.[2014]

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 performanceThese 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 overviewIn 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 BookshelfSleep 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 InformationSymptoms of sleep-wake syndrome include irregular periods of sleep and wakefulness which disrupt the normal daily sleep-wake cycle.
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 ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security