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Completed

NCT Number: NCT00438438

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

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.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Woman's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-35 years old
  • Medically healthy

Exclusion criteria

  • Sleep disorder
  • Psychiatric illness
  • Chronic medical condition
  • No prescription or Non-prescription medications

Treatment and study plan

forced desynchrony protocol with sleep restriction

Behavioral

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 22, 2007
Registry last updated
Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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