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Validation of Circadian Biomarkers in Patients With Sleep Disorders

NCT04690504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-08-06

No results posted yet for this study

Summary

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).

Conditions

  • Sleep Disorders, Circadian Rhythm
  • Circadian Rhythm Disorders
  • Circadian Rhythm Sleep Disorder
  • Advanced Sleep Phase Syndrome (ASPS)
  • Delayed Sleep Phase Syndrome
  • Sleep Wake Disorders
  • Sleep Disorder

Interventions

OTHER

dim light melatonin onset (DLMO)

A series of saliva samples will be collected and assayed for melatonin so that the timing of melatonin secretion onset can be determined.

Sponsors & Collaborators

Principal Investigators

  • Emmanuel Mignot, MD, PhD · Stanford University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-02
Primary Completion
2024-06-30
Completion
2024-07-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690504 on ClinicalTrials.gov