NCT00246454

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

20.6 years

First QC Date

October 27, 2005

Last Update Submit

March 27, 2024

Conditions

Circadian Rhythm Sleep Disorder

Keywords

circadianadvanced sleep phasedelayed sleep phase

Outcome Measures

Primary Outcomes (1)

  • Sleep

    Assessment of sleep parameters

    1 night

Secondary Outcomes (1)

  • Circadian Timing

    3 days

Study Arms (3)

1

People with delayed sleep phase syndrome (DSPS).

2

People with advanced sleep phase syndrome (ASPS).

3

Control group (people with intermediate sleep patterns).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Morning type score on the Horne-Ostberg questionnaire
  • Advanced melatonin onset
  • Evening type score on the Horne-Ostberg questionnaire
  • Delayed melatonin onset
  • A stable sleep/wake pattern with a normal phase relationship to the environment and no history of sleep disorders

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (7)

  • 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.

    BACKGROUND

  • 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.

    PMID: 21527892RESULT

  • Reid KJ, Jaksa AA, Eisengart JB, Baron KG, Lu B, Kane P, Kang J, Zee PC. Systematic evaluation of Axis-I DSM diagnoses in delayed sleep phase disorder and evening-type circadian preference. Sleep Med. 2012 Oct;13(9):1171-7. doi: 10.1016/j.sleep.2012.06.024. Epub 2012 Aug 19.

    PMID: 22910327RESULT

  • Baron KG, Reid KJ, Horn LV, Zee PC. Contribution of evening macronutrient intake to total caloric intake and body mass index. Appetite. 2013 Jan;60(1):246-251. doi: 10.1016/j.appet.2012.09.026. Epub 2012 Oct 2.

    PMID: 23036285RESULT

  • Reid KJ, Santostasi G, Baron KG, Wilson J, Kang J, Zee PC. Timing and intensity of light correlate with body weight in adults. PLoS One. 2014 Apr 2;9(4):e92251. doi: 10.1371/journal.pone.0092251. eCollection 2014.

    PMID: 24694994RESULT

  • Wilson J 4th, Reid KJ, Braun RI, Abbott SM, Zee PC. Habitual light exposure relative to circadian timing in delayed sleep-wake phase disorder. Sleep. 2018 Nov 1;41(11):zsy166. doi: 10.1093/sleep/zsy166.

    PMID: 30423177RESULT

  • Joo EY, Abbott SM, Reid KJ, Wu D, Kang J, Wilson J, Zee PC. Timing of light exposure and activity in adults with delayed sleep-wake phase disorder. Sleep Med. 2017 Apr;32:259-265. doi: 10.1016/j.sleep.2016.09.009. Epub 2016 Nov 9.

    PMID: 27964860RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Phyllis C. Zee, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Benjamin and Virginia T. Boshes Professor of Neurology

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

September 1, 2003

Primary Completion

March 27, 2024

Study Completion

March 27, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)