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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Physiology

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