Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood

January 16, 2026 updated by: Elizabeth Klerman MD PhD, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy
  • BMI between 18.5 and 29.5

Exclusion Criteria:

  • medications
  • recent night-work, shift-work, or travel across >2 time zones
  • use of medications
  • pregnant or within 6 months post-partum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regular Schedule
Participant will be on a regular sleep/wake schedule
Other: Sleep/Wake Schedule
Timing of sleep and wake
Experimental: Irregular Schedule
Participant will be on an irregular sleep/wake schedule
Other: Sleep/Wake Schedule
Timing of sleep and wake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian phase
Time Frame: 27 days
Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment
27 days
Learning
Time Frame: 27 days
Sleep-dependent learning at 3-4 times during inpatient portion of the experiment
27 days
Mood
Time Frame: 27 days
Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment
27 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Elizabeth B Klerman, MD PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimated)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01HL128538 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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