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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Healthy	Behavioral: forced desynchrony protocol with sleep restriction	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated 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 :	April 2006
Actual Primary Completion Date :	November 2008
Actual Study Completion Date :	November 2008

Arms and Interventions

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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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Sleep Stage [ Time Frame: 38 days ]
2. Circadian Phase (melatonin rhythm) [ Time Frame: 38 days ]
3. Psychomotor Vigilance Task [ Time Frame: 38 days ]
4. Digit Symbol Substitution Task [ Time Frame: 38 days ]
5. Addition Task [ Time Frame: 38 days ]
6. Karolinska Sleepiness Scale [ Time Frame: 38 days ]
7. Karolinska Drowsiness Test [ Time Frame: 38 days ]
8. Mood Scales [ Time Frame: 38 days ]
9. Flanker Task [ Time Frame: 38 days ]
10. Multiple Object Tracking [ Time Frame: 38 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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