Circadian Rhythms and Sleep in Familial DSPS and ASPS

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT00246454

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

156

Enrollment

Location

264

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Circadian Rhythm Sleep Disorder

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.

Study Design

Study Type:

Observational

Anticipated 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 :

Sep 1, 2003

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
1 People with delayed sleep phase syndrome (DSPS).
2 People with advanced sleep phase syndrome (ASPS).
3 Control group (people with intermediate sleep patterns).

Outcome Measures

Primary Outcome Measures

Sleep [1 night]
Assessment of sleep parameters

Secondary Outcome Measures

Circadian Timing [3 days]
Assessment of circadian activity profiles

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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