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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02839070
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 61
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual 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: Nov 1, 2016
• Actual Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Circadian phase [27 days]

   Circadian phase, as measured by melatonin, at end vs. beginning of inpatient portion of experiment

2. Learning [27 days]

   Sleep-dependent learning at 3-4 times during inpatient portion of the experiment

3. Mood [27 days]

   Mood (using a linear non-numeric scale) across difference days inpatient portion of the experiment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elizabeth Klerman MD PhD, Associate Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02839070
• Other Study ID Numbers: R01HL128538
• First Posted: Jul 20, 2016
• Last Update Posted: May 20, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Elizabeth Klerman MD PhD, Associate Professor, Brigham and Women's Hospital: Sleep; Learning; Circadian Rhythms

Study Results

No Results Posted as of May 20, 2021