Circadian Rhythm Sleep DisorderNCT00246454
Circadian Rhythms and Sleep in Familial DSPS and ASPS
An observational study of Circadian Rhythm Sleep Disorder, run by Northwestern University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circadian Rhythm Sleep Disorder
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to 27 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with circadian rhythm sleep disorders and healthy age and gender matched controls
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Circadian Rhythm Sleep Disorder
- Keywords
- circadian, advanced sleep phase, delayed sleep phase
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Assessment of sleep parameters
Measured: 1 night
Secondary outcomes (1)
Circadian Timing
Assessment of circadian activity profiles
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startSep 2003
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Circadian Rhythm Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Phyllis Zee, Northwestern University
- Investigators
- Phyllis C. Zee, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246454
- Sponsor's protocol ID
- 341
- Other IDs
- R01HL069988
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2005
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 21527892Reid 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.
PubMed 22910327Baron 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.
PubMed 23036285Reid 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.
PubMed 24694994Wilson 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.
PubMed 30423177Joo 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.
PubMed 27964860
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythms and Sleep in Familial Delayed Sleep Phase Syndrome (DSPS) and Advanced Sleep Phase Syndrome (ASPS)
- ClinicalTrials.gov ID
- NCT00246454
- Acronym / sponsor ID
- 341
- Conditions
- Circadian Rhythm Sleep Disorder
- Keywords
- circadian, advanced sleep phase, delayed sleep phase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –People with delayed sleep phase syndrome (DSPS). |
| 2 | – | –People with advanced sleep phase syndrome (ASPS). |
| 3 | – | –Control group (people with intermediate sleep patterns). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with circadian rhythm sleep disorders and healthy age and gender matched controls
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep
Time frame: 1 night
Assessment of sleep parameters
1 secondary outcome
Circadian Timing
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- BackgroundReid 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.
- Results publication: PubMed 21527892Baron 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.
- Results publication: PubMed 22910327Reid 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.
- Results publication: PubMed 23036285Baron 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.
- Results publication: PubMed 24694994Reid 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.
- Results publication: PubMed 30423177Wilson 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.
- Results publication: PubMed 27964860Joo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis C. Zee, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm Sleep Disorder, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246454, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.