Circadian Rhythms and Sleep in Familial DSPS and ASPS

March 27, 2024 updated by: Phyllis Zee, Northwestern University

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 1 night
Assessment of sleep parameters
1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circadian Timing
Time Frame: 3 days
Assessment of circadian activity profiles
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Phyllis C. Zee, MD, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

March 27, 2024

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

October 27, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimated)

October 30, 2005

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 341
  • R01HL069988 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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