Circadian Rhythm Monitoring Study

ConditionCircadian Rhythm

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorResMed

About this trial

This will be a single-center, prospective observational study designed to evaluate the feasibility and accuracy of a new wearable device for non-invasive continuous monitoring of physiological signals to derive circadian rhythm. Melatonin sampling will be included for comparison against wearable-derived measures

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults ≥18 years at screening.

Able and willing to provide written informed consent.

Belonging to one of three strata: (a) healthy controls without diagnosed sleep disorder, (b) patients with physician-diagnosed OSA, or (c) patients with physician-diagnosed insomnia (based on DSM-5/AASM criteria and ISI ≥15)

Capable of using a smartphone for app-based data syncing.

Disqualifiers

• Dermatologic conditions preventing wearable use.

Significant psychiatric or neurologic illness that may impair compliance.

Shift work or trans-meridian travel within 2 weeks prior.

Currently pregnant

Trial design

Design model

Single group

Treatments tested in this trial

Circadian monitoring device
Device
This is a new wearable device for non-invasive continuous monitoring of physiological signals to derive circadian rhythm

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Circadian rhythm monitoringExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Feasibility of estimating circadian phase with the myCircadian wearable device. Correlation

Circadian phase estimated by the myCircadian wearable device (expressed as clock time of circadian phase in hours) will be compared with circadian phase determined by salivary melatonin sampling, defined as dim-light melatonin onset (DLMO; first salivary melatonin concentration ≥3 pg/mL and ≥2 standard deviations above baseline, expressed in clock time). The strength of agreement between the two measures will be assessed using Pearson correlation coefficient (r).

Time frame

48 hours

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ResMed

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: