Circadian Rhythms and Sleep in Familial DSPS and ASPS

Circadian Rhythm Sleep Disorder Clinical Trial

Official title:

Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246454
• Other study ID #: 341
• Secondary ID: R01HL069988
• Status: Completed
• Start date: September 2003
• Est. completion date: March 27, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.2012.06.02 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Assessment of sleep parameters	1 night
Secondary	Circadian Timing	Assessment of circadian activity profiles	3 days