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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00438438
Collaborator
(none)
9
1
31
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: forced desynchrony protocol with sleep restriction
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
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"
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Sleep Stage [38 days]

  2. Circadian Phase (melatonin rhythm) [38 days]

  3. Psychomotor Vigilance Task [38 days]

  4. Digit Symbol Substitution Task [38 days]

  5. Addition Task [38 days]

  6. Karolinska Sleepiness Scale [38 days]

  7. Karolinska Drowsiness Test [38 days]

  8. Mood Scales [38 days]

  9. Flanker Task [38 days]

  10. Multiple Object Tracking [38 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00438438
Other Study ID Numbers:
  • 2200-100792
First Posted:
Feb 22, 2007
Last Update Posted:
Sep 2, 2011
Last Verified:
Aug 1, 2011
Keywords provided by Elizabeth B. Klerman, Associate Professor, Associate Physician, Brigham and Women's Hospital

Study Results

No Results Posted as of Sep 2, 2011