Circadian Rhythms and Sleep in Familial DSPS and ASPS | NCT00246454

Studies
Circadian Rhythms and Sleep in Familial DSPS and ASPS

NCT00246454

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Mar 29, 2024Actual

Enrollment

156Actual

Phase

Not provided

Conditions

Circadian Rhythm Sleep Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01HL069988	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Mar 27, 2024Actual

Completion Date

Mar 27, 2024Actual

First Submitted Date

Oct 27, 2005

First Submission Date that Met QC Criteria

Oct 27, 2005

First Posted Date

Oct 31, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2024

Last Update Posted Date

Mar 29, 2024Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

156Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		People with delayed sleep phase syndrome (DSPS).
2		People with advanced sleep phase syndrome (ASPS).
3		Control group (people with intermediate sleep patterns).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep	Assessment of sleep parameters	1 night

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Phyllis C. Zee, MD, PhD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

References Module

Citations

PubMed Identifier	Type	Citation
	Background	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.
21527892	Result	Baron KG, Reid KJ, Kern AS, Zee PC. Role of sleep timing in caloric intake and BMI. Obesity (Silver Spring). 2011 Jul;19(7):1374-81. doi: 10.1038/oby.2011.100. Epub 2011 Apr 28.
22910327

ID	Term
D021081	Chronobiology Disorders
D009422	Nervous System Diseases
D020920	Dyssomnias
D012893	Sleep Wake Disorders