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

October 27, 2005
November 6, 2014
September 2003
September 2015   (final data collection date for primary outcome measure)
Sleep [ Time Frame: 1 night ] [ Designated as safety issue: No ]
Assessment of sleep parameters
Not Provided
Complete list of historical versions of study NCT00246454 on ClinicalTrials.gov Archive Site
Circadian Timing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Assessment of circadian activity profiles
Not Provided
Not Provided
Not Provided
 
Circadian Rhythms and Sleep in Familial DSPS and ASPS
Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (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 and actigraphy to determine sleep patterns and quality.

Observational
Not Provided
Not Provided
Retention:   Samples Without DNA
Description:

plasma

Non-Probability Sample

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

Circadian Rhythm Sleep Disorder
Not Provided
  • 1
    People with delayed sleep phase syndrome (DSPS).
  • 2
    People with advanced sleep phase syndrome (ASPS).
  • 3
    Control group (people with intermediate sleep patterns).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
156
September 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sabra Abbott, MD, PhD 312-503-3561 sabra.abbott@northwestern.edu
United States
 
NCT00246454
341, R01HL069988, R01 HL069988
No
Phyllis Zee, Northwestern University
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Phyllis C. Zee, MD, PhD Northwestern University
Northwestern University
November 2014

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