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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: Completed study, sponsored by Brigham and Women's Hospital.
NCT04690504 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
dim light melatonin onset, the time at which melatonin levels in the saliva rise above 3pg/mL
Interventions
- OTHER dim light melatonin onset (DLMO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2024-07-01 |
What the finished NCT04690504 record still lists
NCT04690504 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which dim light melatonin onset (DLMO) is the first listed.
NCT04690504 does not publish any study locations in the registry export this page uses.
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.
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