NCT02839070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

July 15, 2016

Last Update Submit

January 16, 2026

Conditions

Physiology

Keywords

SleepLearningCircadian Rhythms

Outcome Measures

Primary Outcomes (3)

  • Circadian phase

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

    27 days

  • Learning

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

    27 days

  • Mood

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

    27 days

Study Arms (2)

Regular Schedule

EXPERIMENTAL

Participant will be on a regular sleep/wake schedule

Other: Sleep/Wake Schedule

Irregular Schedule

EXPERIMENTAL

Participant will be on an irregular sleep/wake schedule

Other: Sleep/Wake Schedule

Interventions

Sleep/Wake ScheduleOTHER

Timing of sleep and wake

Irregular ScheduleRegular Schedule

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • BMI between 18.5 and 29.5

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Elizabeth B Klerman, MD PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 20, 2016

Study Start

November 1, 2016

Primary Completion

April 1, 2021

Study Completion

December 1, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(1)