Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
"Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"
1 other identifier
interventional
9
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Apr 2006
Longer than P75 for not_applicable healthy
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedSeptember 2, 2011
August 1, 2011
2.6 years
February 20, 2007
August 31, 2011
Conditions
Keywords
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
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
Study Officials
- PRINCIPAL INVESTIGATOR
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
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