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Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438438
First Posted: February 22, 2007
Last Update Posted: September 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital
  Purpose
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.

Condition Intervention
Healthy Behavioral: forced desynchrony protocol with sleep restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: "Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"

Resource links provided by NLM:


Further study details as provided by Elizabeth B. Klerman, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sleep Stage [ Time Frame: 38 days ]
  • Circadian Phase (melatonin rhythm) [ Time Frame: 38 days ]
  • Psychomotor Vigilance Task [ Time Frame: 38 days ]
  • Digit Symbol Substitution Task [ Time Frame: 38 days ]
  • Addition Task [ Time Frame: 38 days ]
  • Karolinska Sleepiness Scale [ Time Frame: 38 days ]
  • Karolinska Drowsiness Test [ Time Frame: 38 days ]
  • Mood Scales [ Time Frame: 38 days ]
  • Flanker Task [ Time Frame: 38 days ]
  • Multiple Object Tracking [ Time Frame: 38 days ]

Estimated Enrollment: 9
Study Start Date: April 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: forced desynchrony protocol with sleep restriction
    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.
Detailed Description:
This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10 hour sleep opportunities. This will allow assessment of the independent contributions of circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours.
  Eligibility

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-35 years old
  • Medically healthy

Exclusion Criteria:

  • Sleep disorder
  • Psychiatric illness
  • Chronic medical condition
  • No prescription or Non-prescription medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438438


Locations
United States, Massachusetts
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
  More Information

Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00438438     History of Changes
Other Study ID Numbers: 2200-100792
First Submitted: February 20, 2007
First Posted: February 22, 2007
Last Update Posted: September 2, 2011
Last Verified: August 2011

Keywords provided by Elizabeth B. Klerman, Brigham and Women's Hospital:
forced desynchrony
circadian rhythms
sleep restriction
sleep homeostasis
neurobehavioral performance