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Examining the Biological Factors That Affect Sleep Duration

This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2008

Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00607204
  Purpose

Sleep is necessary for healthy functioning, and people who sleep too little or too much may have an increased risk of developing health problems. This study will examine people who regularly sleep for short or long amounts of time to understand the biological factors that determine how much sleep a person needs.


Condition
Sleep
Circadian Rhythm
Cognitive Performance

Drug Information available for:   Melatonin   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Neurobiology of Individual Differences in Sleep Duration

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Circadian rhythm assessment based on plasma melatonin and other hormones; sleep and EEG analysis; measurements of cognitive performance, alertness, and mood [ Time Frame: Measured during the 4-week inpatient stay ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   October 2005
Estimated Study Completion Date:   April 2010
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

Detailed Description:

The amount of sleep people require depends on many factors, including age, but experts agree that most adults need 7 to 8 hours of sleep a night. People who sleep for shorter or longer amounts of time may be at risk of developing memory problems, heart disease, obesity, and diabetes. The duration and timing of sleep are regulated by an interaction between the circadian pacemaker, or biological clock, and the sleep homeostat, which is an internal account of the amount of sleep a person has received recently. It is unknown whether there is a biological or genetic basis for the amount of sleep a person needs. This inpatient study will examine two extreme sleep groups: short sleepers who sleep 6.5 or less hours a night and long sleepers who sleep 9 or more hours a night. Participants will be exposed to identical sleep opportunities and living conditions. Using hormone analysis to examine participants' circadian rhythms, researchers will evaluate the biological differences that people undergo during the sleep process. Results from this study may help researchers understand whether sleep duration and sleep needs differ among people because of biological and genetic variations.

Over a period of 4 to 6 weeks, potential study participants will attend 4 to 6 screening visits, which will include a medical history review, physical exam, blood and urine collection, electrocardiogram (EKG) to measure electrical activity of the heart, a psychological assessment, and an overnight stay in a sleep laboratory. For 3 weeks, potential participants will also wear an activity monitor, and they will record sleep habits electronically and in a daily diary.

Participants who are eligible for the study will spend 28 days in the Intensive Physiological Monitoring Unit of the Clinical and Translational Sciences Center at the Brigham and Women's Hospital. Participants will not have access to a clock, radio, television, or computer, and they will not be allowed any outside contact. Most days participants will remain in bed for 10 to 14 hours; however, at selected times during the study, participants will remain inactive for periods of 32 to 64 hours and will stay awake for 32 to 40 hours. Throughout the study, participants' sleep patterns will be monitored continuously by a wrist activity recorder. Heart rhythms, brain electrical activity, eye movements, and temperature will also be measured continuously. At different times throughout the study, participants will undergo urine, saliva, and blood collection; alertness, mood, and performance evaluations; and blood pressure measurements. Upon release from the research center, participants will maintain a sleep diary for 3 weeks.

  Eligibility
Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

Participants will include healthy people who are catagorized as either short sleepers or long sleepers.


Criteria

Inclusion Criteria:

  • Routinely sleeps 6.5 hours or less a night, or routinely sleeps 9 hours or more a night
  • In good health

Exclusion Criteria:

  • Diagnosed with a sleep disorder
  • Currently uses medications
  • Performed night shift work in the 3 years before study entry
  • History of psychiatric illness
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607204

Contacts
Contact: Kate Berkenbush     617-732-7917     research@rics.bwh.harvard.edu    

Locations
United States, Massachusetts
Brigham & Women's Hospital     Recruiting
      Boston, Massachusetts, United States, 02115
      Contact: Daniel Aeschbach, PhD     617-732-5204     daeschbach@hms.harvard.edu    
      Sub-Investigator: Charles A. Czeisler, PhD, MD            
      Sub-Investigator: Suman Baddam, MD            
      Sub-Investigator: Anne-Marie Chang, PhD            
      Sub-Investigator: Melodee Mograss, Ph.D.            

Sponsors and Collaborators

Investigators
Principal Investigator:     Daniel Aeschbach, PhD     Brigham & Women's Hospital, Boston, MA    
  More Information


Click here for the Division of Sleep Medicine at Harvard Medical School Web site  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Brigham & Women's Hospital ( Daniel Aeschbach, PhD )
Study ID Numbers:   559, R01 HL077399
First Received:   February 4, 2008
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00607204
Health Authority:   United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Basic Research  
Individual Sleep Duration  
Melatonin  
Electroencephalogram
Alertness
Mood

Study placed in the following topic categories:
Melatonin

ClinicalTrials.gov processed this record on November 06, 2008




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