- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00438438
Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance
August 31, 2011 updated by: Elizabeth B. Klerman, Brigham and Women's Hospital
"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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Woman's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-35 years old
- Medically healthy
Exclusion Criteria:
- Sleep disorder
- Psychiatric illness
- Chronic medical condition
- No prescription or Non-prescription medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep Stage
Time Frame: 38 days
|
38 days
|
Circadian Phase (melatonin rhythm)
Time Frame: 38 days
|
38 days
|
Psychomotor Vigilance Task
Time Frame: 38 days
|
38 days
|
Digit Symbol Substitution Task
Time Frame: 38 days
|
38 days
|
Addition Task
Time Frame: 38 days
|
38 days
|
Karolinska Sleepiness Scale
Time Frame: 38 days
|
38 days
|
Karolinska Drowsiness Test
Time Frame: 38 days
|
38 days
|
Mood Scales
Time Frame: 38 days
|
38 days
|
Flanker Task
Time Frame: 38 days
|
38 days
|
Multiple Object Tracking
Time Frame: 38 days
|
38 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (ACTUAL)
November 1, 2008
Study Completion (ACTUAL)
November 1, 2008
Study Registration Dates
First Submitted
February 20, 2007
First Submitted That Met QC Criteria
February 21, 2007
First Posted (ESTIMATE)
February 22, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2011
Last Update Submitted That Met QC Criteria
August 31, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2200-100792
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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