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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839070
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physiology Other: Sleep/Wake Schedule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influence of Sleep Regularity on Circadian Rhythms, Learning, Performance, and Mood
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Circadian phase [ Time Frame: 27 days ]
    Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment

  2. Learning [ Time Frame: 27 days ]
    Sleep-dependent learning at 3-4 times during inpatient portion of the experiment

  3. Mood [ Time Frame: 27 days ]
    Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839070


Contacts
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Contact: Elizabeth B Klerman, MD PhD 617-732-8145 ebklerman@research.bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Matthew Mayer    617-732-4311    light@research.bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Elizabeth B Klerman, MD PhD Brigham and Women's Hospital
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Responsible Party: Elizabeth B. Klerman, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02839070    
Other Study ID Numbers: R01HL128538 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Elizabeth B. Klerman, Brigham and Women's Hospital:
Sleep
Learning
Circadian Rhythms