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Circadian Rhythms and Sleep in Familial DSPS and ASPS

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ClinicalTrials.gov Identifier: NCT00246454
Recruitment Status : Recruiting
First Posted : October 30, 2005
Last Update Posted : May 5, 2021
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Phyllis Zee, Northwestern University

Brief Summary:
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).

Condition or disease
Circadian Rhythm Sleep Disorder

Detailed Description:


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.


Participants will complete questionnaires and actigraphy to determine sleep patterns and quality.

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Study Type : Observational
Estimated Enrollment : 156 participants
Observational Model: Other
Time Perspective: Other
Official Title: Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)
Study Start Date : September 2003
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

People with delayed sleep phase syndrome (DSPS).
People with advanced sleep phase syndrome (ASPS).
Control group (people with intermediate sleep patterns).

Primary Outcome Measures :
  1. Sleep [ Time Frame: 1 night ]
    Assessment of sleep parameters

Secondary Outcome Measures :
  1. Circadian Timing [ Time Frame: 3 days ]
    Assessment of circadian activity profiles

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with circadian rhythm sleep disorders and healthy age and gender matched controls

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 polysomnogram
  • History of cognitive or other neurological disorders
  • History of Diagnostic and Statistical Manual-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246454

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Contact: Sabra Abbott, MD, PhD 312-503-3561 sabra.abbott@northwestern.edu

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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Sabra Abbott    312-503-3561    sabra.abbott@northwestern.edu   
Principal Investigator: Phyllis C. Zee, MD, PhD         
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Phyllis C. Zee, MD, PhD Northwestern University
Publications of Results:
Other Publications:
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.

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Responsible Party: Phyllis Zee, Benjamin and Virginia T. Boshes Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT00246454    
Other Study ID Numbers: 341
R01HL069988 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2005    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Phyllis Zee, Northwestern University:
advanced sleep phase
delayed sleep phase
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Mental Disorders
Chronobiology Disorders
Occupational Diseases