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Not yet recruiting NCT07336654

Circadian Rhythm Monitoring Study

No phase Interventional Circadian Rhythm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Circadian monitoring device.
Who it may be relevant to
Registry conditions: Circadian Rhythm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of a Novel Wearable Device for Circadian Rhythm Monitoring in Healthy, OSA, and Insomnia Participants

Overview

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

Interventions

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

Primary outcome measures

  • Feasibility of estimating circadian phase with the myCircadian wearable device. Correlation [Time frame: 48 hours]

Eligibility criteria

Inclusion criteria

  • 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.
  • Willing to comply with study visits, wearable use, and saliva sampling.

Exclusion criteria

  • • 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
  • Use of medications known to significantly alter circadian rhythm (e.g., exogenous melatonin, beta-blockers).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07336654 · MA250925

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗