Sleep/Wake Schedule for Physiology

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Medications

Disqualifiers: Pregnant, Recent shift-work, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

Trial Summary

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 data supports the effectiveness of the Sleep/Wake Schedule treatment?

Research shows that improving sleep in hospital settings can reduce stress, improve healing, and decrease episodes of delirium (confusion). A structured sleep program in intensive care units has been linked to better patient satisfaction and outcomes. ^{1 2 3 4 5}

Is the Sleep/Wake Schedule generally safe for humans?

Research suggests that the timing of sleep and wake cycles can affect how the body processes drugs, which can influence their safety and effectiveness. While specific safety data for the Sleep/Wake Schedule itself is not detailed, understanding and aligning with natural circadian rhythms can help minimize potential side effects and improve overall safety. ^{6 7 8 9 10}

How does the sleep/wake schedule treatment differ from other treatments for sleep disorders?

The sleep/wake schedule treatment is unique because it focuses on aligning the sleep-wake cycle with the body's internal circadian rhythms and external light-dark cycles, rather than using medication. This approach aims to naturally regulate sleep patterns by adjusting the timing of sleep and wakefulness, which can be particularly beneficial for individuals with disrupted circadian rhythms. ^{11 12 13 14 15}

What is the purpose of this trial?

The study is a combination of outpatient and inpatient monitoring. During the 27-day inpatient portion of the study, the individual's sleep-wake schedule will be varied daily. Volunteers will be randomized to a regular or irregular inpatient schedule.

Research Team

Elizabeth B Klerman, MD PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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?

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Regular Schedule Experimental Treatment 1 Intervention

Participant will be on a regular sleep/wake schedule

Group II: Irregular Schedule Experimental Treatment 1 Intervention

Participant will be on an irregular sleep/wake schedule

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Hata, RK., Han, L., Slade, J., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep in the intensive care unit. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A prospective multicentre observational study to quantify nocturnal light exposure in intensive care. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. [2014]

4. India pubmed.ncbi.nlm.nih.gov

Quality of sleep and its related risk factors in hospitalized older patients in Kashan's Hospitals, Iran 2009. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Positive and negative effects of mechanical ventilation on sleep in the ICU: a review with clinical recommendations. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Chronopharmaceutics: pharmaceutics focused on biological rhythm. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Brain function and effects of shift work: implications for clinical neuropharmacology. [2018]

8. Japan pubmed.ncbi.nlm.nih.gov

Chrono-Pharmaceutical Approaches to Optimize Dosing Regimens Based on the Circadian Clock Machinery. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Chronotherapy: Intuitive, Sound, Founded…But Not Broadly Applied. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Circadian Effects of Drug Responses. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Integration of human sleep-wake regulation and circadian rhythmicity. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Timing is everything: Circadian rhythms and their role in the control of sleep. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Further discussion of a model of the REM sleep oscillator. [2017]

14. United States pubmed.ncbi.nlm.nih.gov

Modeling interindividual differences in spontaneous internal desynchrony patterns. [2013]

15. France pubmed.ncbi.nlm.nih.gov

[Normal organization of sleep and its changes during life]. [2020]