Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00246454
First received: October 27, 2005
Last updated: July 19, 2012
Last verified: July 2012

October 27, 2005
July 19, 2012
September 2003
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Complete list of historical versions of study NCT00246454 on ClinicalTrials.gov Archive Site
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Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)
Circadian Rhythms and Sleep in Familial DSPS and ASPS

The purpose of this study is to determine the properties of circadian rhythms and sleep propensity in familial advanced and delayed sleep phase syndrome (DSPS).

BACKGROUND:

Tremendous progress in the past few years has led to the identification of several circadian clock genes. This now makes it possible to determine how alterations of human circadian clock genes and their expression could lead to differences in circadian and sleep/wake cycle phenotypes. Of particular interest for understanding genetics of the human circadian system are individuals with sleep phase disorders, such as DSPS and advanced sleep phase syndrome (ASPS), because recent studies indicate a genetic basis for these disorders. While it is assumed that both ASPS and DSPS are disorders of circadian timing, little is known about how the circadian clock system, or its interaction with sleep processes, are affected in these individuals.

DESIGN NARRATIVE:

Participants will complete questionnaires to determine sleep quality.

Observational
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Retention:   Samples Without DNA
Description:

Plasma

Non-Probability Sample

Subjects with circadian rhythm sleep disorders and healthy age and gender matched controls

Sleep
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  • 1
    People with delayed sleep phase syndrome (DSPS).
  • 2
    People with advanced sleep phase syndrome (ASPS).
  • 3
    Control group.
Reid K. J., Zee P.C. (2005) Circadian Disorders of the Sleep-Wake Cycle. Kryger, Roth, Dement (ed's) Principle and Practices of Sleep Medicine, 4th Ed. Saunders.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
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Inclusion Criteria for ASPS Participants:

  • Morning type score on the Horne-Ostberg questionnaire
  • Advanced melatonin onset

Inclusion Criteria for DSPS Participants:

  • Evening type score on the Horne-Ostberg questionnaire
  • Delayed melatonin onset

Inclusion Criteria for Controls:

  • A stable sleep/wake pattern with a normal phase relationship to the environment and no history of sleep disorders

Exclusion Criteria for all subjects:

  • Sleep disorder, other than DSPS or ASPS, as assessed by the Pittsburgh Sleep Quality Index and/or by PSG
  • History of cognitive or other neurological disorders
  • History of DSM-IV criteria for any major psychiatric disorder, alcohol or substance abuse
  • Abnormal mood as assessed by the Hamilton Depression Scale
  • History of, or concurrent, unstable or serious medical illness
  • Current use of psychoactive medications, including antidepressants, anxiolytics, neuroleptics, anticonvulsants, hypnotics, and stimulant medications
  • Shift work
  • Having a daily caffeine intake greater than 4 cups per day
  • Smoking
  • Travel across more than 2 time zones within 90 days of the study
  • Pregnancy or the desire to become pregnant during the study period
Both
18 Years and older
No
United States
 
NCT00246454
341, R01HL069988, R01 HL069988
No
Phyllis C. Zee, Northwestern University
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Phyllis C. Zee, MD, PhD Northwestern University
Northwestern University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP