NCT00438438

Brief Summary

The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep homeostasis that can predict the effects of chronic sleep restriction. This model will be based on the underlying neuroanatomy and neurophysiology. This new model will facilitate optimization of human performance in operational settings, such as are seen in military operation and other work environments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 2, 2011

Status Verified

August 1, 2011

Enrollment Period

2.6 years

First QC Date

February 20, 2007

Last Update Submit

August 31, 2011

Conditions

Keywords

forced desynchronycircadian rhythmssleep restrictionsleep homeostasisneurobehavioral performance

Outcome Measures

Primary Outcomes (10)

  • Sleep Stage

    38 days

  • Circadian Phase (melatonin rhythm)

    38 days

  • Psychomotor Vigilance Task

    38 days

  • Digit Symbol Substitution Task

    38 days

  • Addition Task

    38 days

  • Karolinska Sleepiness Scale

    38 days

  • Karolinska Drowsiness Test

    38 days

  • Mood Scales

    38 days

  • Flanker Task

    38 days

  • Multiple Object Tracking

    38 days

Interventions

Subjects are scheduled to live on a non-24 hour day. This separates the sleep-wake schedule from the near-24 hour circadian rhythm. This allows assessment of how circadian rhythms and the length-of-time awake contribute to sleepiness, alertness, and cognitive performance.

Eligibility Criteria

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

You may qualify if:

  • Age 18-35 years old
  • Medically healthy

You may not qualify if:

  • Sleep disorder
  • Psychiatric illness
  • Chronic medical condition
  • No prescription or Non-prescription medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Woman's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Elizabeth B Klerman, M.D., Ph.D.

    Brigham and Woman's Hospital

    PRINCIPAL INVESTIGATOR
  • Charles A Czeisler, Ph.D., M.D.

    Brigham and Woman's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Associate Physician

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

April 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 2, 2011

Record last verified: 2011-08

Locations