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NCT02839070 Clinical Trial

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

Physiology Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02839070
Other study ID # R01HL128538
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date December 2023

Study information
Verified date February 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 27
Est. completion date December 2023
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Sleep/Wake Schedule
Timing of sleep and wake

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

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