Validation of Circadian Biomarkers in Patients With Sleep Disorders
Proteomic and Transcriptomic Biomarkers of Circadian Timing - Validation of Circadian Biomarkers in Patients With Sleep Disorders
Proteomic and Transcriptomic Biomarkers of Circadian Timing - Validation of Circadian Biomarkers in Patients With Sleep Disorders
Sponsor study identifier
observational
50
1 country
1
Study Start
November 2, 2021
Actual (reported)Primary Completion
June 30, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estimate individual circadian time with a single blood sample taken at any time of the day or night. To do this, the investigators will use two state of the art methods, a plasma proteomics-based method to identify a panel of rhythmic proteins (extending our preliminary data) and a whole blood-derived monocyte-based method using a panel of 15 transcripts (to validate and extend a recent study). We will test both methods in a series of patients with circadian rhythm sleep disorders. We will validate separately the proteomics-based biomarker and the monocyte-based transcript biomarker, and also explore whether combining them can improve the accuracy of our timing estimates. In all cases, circadian phase estimates from the biomarker panels will be compared with those derived from plasma or saliva melatonin (the current "gold-standard" circadian phase marker).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2020
Actual (reported)December 30, 2020
Actual (reported)November 2, 2021
Actual (reported)June 30, 2024
Actual (reported)July 1, 2024
Actual (reported)DLMO
dim light melatonin onset, the time at which melatonin levels in the saliva rise above 3pg/mL
Study Day 1
BodyTime
the time at which a series of rhythmic gene transcripts predict circadian phase
Study Day 1
PlasmaTime
the time at which a series of rhythmic proteins predict circadian phase
Study Day 1
A series of saliva samples will be collected and assayed for melatonin so that the timing of melatonin secretion onset can be determined.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy adults who meet ICSD-3 criteria for Advanced Sleep Wake Phase Disorder (ASWPD) or Delayed Sleep Wake Phase Disorder (DSWPD).
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Saliva samples will be collected and assayed for melatonin. Blood samples will be collected and assayed for rhythmic gene transcripts and rhythmic proteins. A blood sample will be collected for DNA analysis, including potential GWAS.
Emmanuel Mignot, MD, PhD
Stanford University
50 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2020
First Posted
December 30, 2020
Study Start
November 2, 2021
Actual (reported)Light Sensitization Study
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Last Updated
August 6, 2024
Record last verified: 2024-08
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Source: ClinicalTrials.gov.
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