Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04690504 · ClinicalTrials.gov registry record

Validation of Circadian Biomarkers in Patients With Sleep Disorders

A clinical trial, sponsored by Brigham and Women's Hospital.

Completed
Registry status
50
Enrollment target

NCT04690504 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 50 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04690504 has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
50 participants
Enrollment target

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).

Interventions

  • OTHER dim light melatonin onset (DLMO)

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-11-02
Est. Completion 2024-07-01

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT04690504

The ClinicalTrials.gov registry entry for NCT04690504 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which dim light melatonin onset (DLMO) is the first listed.

NCT04690504 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04690504 about?

NCT04690504 is a clinical study titled "Validation of Circadian Biomarkers in Patients With Sleep Disorders". 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 d...

What is the current status of trial NCT04690504?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2021-11-02. Estimated completion is 2024-07-01.

What interventions are being tested in trial NCT04690504?

The interventions under investigation include: dim light melatonin onset (DLMO) (OTHER).

Who is sponsoring clinical trial NCT04690504?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.