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Sleep/Wake Schedule for Physiology

N/A
Waitlist Available
Led By Elizabeth B Klerman, MD PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 days
Awards & highlights
No Placebo-Only Group

Summary

This trialtests the effects of varying sleep-wake schedules on volunteers over 27 days, with some randomized to a regular and some to an irregular schedule.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves changes to sleep patterns rather than medication, side effects may include tiredness, irritability, difficulty concentrating or memory issues due to disruption of normal sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Circadian phase
Learning
Mood

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Regular ScheduleExperimental Treatment1 Intervention
Participant will be on a regular sleep/wake schedule
Group II: Irregular ScheduleExperimental Treatment1 Intervention
Participant will be on an irregular sleep/wake schedule

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,439 Total Patients Enrolled
Elizabeth B Klerman, MD PhDPrincipal InvestigatorBrigham and Women's Hospital
8 Previous Clinical Trials
1,015 Total Patients Enrolled

Media Library

Regular Schedule Clinical Trial Eligibility Overview. Trial Name: NCT02839070 — N/A
Physiology Research Study Groups: Regular Schedule, Irregular Schedule
Physiology Clinical Trial 2023: Regular Schedule Highlights & Side Effects. Trial Name: NCT02839070 — N/A
Regular Schedule 2023 Treatment Timeline for Medical Study. Trial Name: NCT02839070 — N/A
~3 spots leftby Dec 2025
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