Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Elizabeth B. Klerman, Brigham and Women's Hospital Identifier:
First received: February 20, 2007
Last updated: August 31, 2011
Last verified: August 2011

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
Behavioral: forced desynchrony protocol with sleep restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sleep Stage [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Circadian Phase (melatonin rhythm) [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Psychomotor Vigilance Task [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Task [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Addition Task [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Karolinska Sleepiness Scale [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Karolinska Drowsiness Test [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Mood Scales [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Flanker Task [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  • Multiple Object Tracking [ Time Frame: 38 days ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00438438

United States, Massachusetts
Brigham and Woman's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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

No publications provided

Responsible Party: Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital Identifier: NCT00438438     History of Changes
Other Study ID Numbers: 2200-100792
Study First Received: February 20, 2007
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
forced desynchrony
circadian rhythms
sleep restriction
sleep homeostasis
neurobehavioral performance processed this record on March 03, 2015