Circadian Rhythms and Sleep in Familial DSPS and ASPS

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phyllis Zee, Northwestern University
ClinicalTrials.gov Identifier:
NCT00246454
First received: October 27, 2005
Last updated: November 6, 2014
Last verified: November 2014
  Purpose

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
Circadian Rhythm Sleep Disorder

Study Type: Observational
Official Title: Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]
    Assessment of sleep parameters


Secondary Outcome Measures:
  • Circadian Timing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Assessment of circadian activity profiles


Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 156
Study Start Date: September 2003
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
People with delayed sleep phase syndrome (DSPS).
2
People with advanced sleep phase syndrome (ASPS).
3
Control group (people with intermediate sleep patterns).

Detailed Description:

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 and actigraphy to determine sleep patterns and quality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246454

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

Locations
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
Investigators
Principal Investigator: Phyllis C. Zee, MD, PhD Northwestern University
  More Information

Publications:
Responsible Party: Phyllis Zee, Benjamin and Virginia T. Boshes Professor of Neurology, Northwestern University
ClinicalTrials.gov Identifier: NCT00246454     History of Changes
Other Study ID Numbers: 341, R01HL069988, R01 HL069988
Study First Received: October 27, 2005
Last Updated: November 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
circadian
advanced sleep phase
delayed sleep phase

Additional relevant MeSH terms:
Parasomnias
Sleep Disorders
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Occupational Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 01, 2015