Clinical trial NCT00438438: Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
Official title: "Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: forced desynchrony
circadian rhythms
sleep restriction
sleep homeostasis
neurobehavioral performance
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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

Primary outcomes:
measure: Sleep Stage
timeFrame: 38 days
measure: Circadian Phase (melatonin rhythm)
timeFrame: 38 days
measure: Psychomotor Vigilance Task
timeFrame: 38 days
measure: Digit Symbol Substitution Task
timeFrame: 38 days
measure: Addition Task
timeFrame: 38 days
measure: Karolinska Sleepiness Scale
timeFrame: 38 days
measure: Karolinska Drowsiness Test
timeFrame: 38 days
measure: Mood Scales
timeFrame: 38 days
measure: Flanker Task
timeFrame: 38 days
measure: Multiple Object Tracking
timeFrame: 38 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Woman's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Woman's Hospital
name: Elizabeth B Klerman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Woman's Hospital
name: Charles A Czeisler, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: