NCT01581125

Brief Summary

The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

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

March 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

4.2 years

First QC Date

March 22, 2012

Last Update Submit

July 15, 2016

Conditions

Keywords

InpatientsHealth Normalcycircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • Psychomotor Vigilance Task (PVT) performance

    PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol.

    PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol

Study Arms (2)

Sleep:wake 2

EXPERIMENTAL

Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1.

Behavioral: Sleep:wake 2

Sleep:wake 1

EXPERIMENTAL

Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2.

Behavioral: Sleep:wake 1

Interventions

Sleep:wake 1BEHAVIORAL

Sleep and Wake durations for arm 1

Sleep:wake 1
Sleep:wake 2BEHAVIORAL

Sleep and Wake durations for arm2

Sleep:wake 2

Eligibility Criteria

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

You may qualify if:

  • Healthy

You may not qualify if:

  • Prescription medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • McHill AW, Hull JT, Cohen DA, Wang W, Czeisler CA, Klerman EB. Chronic sleep restriction greatly magnifies performance decrements immediately after awakening. Sleep. 2019 May 1;42(5):zsz032. doi: 10.1093/sleep/zsz032.

  • McHill AW, Hull JT, McMullan CJ, Klerman EB. Chronic Insufficient Sleep Has a Limited Impact on Circadian Rhythmicity of Subjective Hunger and Awakening Fasted Metabolic Hormones. Front Endocrinol (Lausanne). 2018 Jun 12;9:319. doi: 10.3389/fendo.2018.00319. eCollection 2018.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Physician

Study Record Dates

First Submitted

March 22, 2012

First Posted

April 19, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations