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NCT Number: NCT07336654

Circadian Rhythm Monitoring Study

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

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Key information

Conditions

Circadian Rhythm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Circadian monitoring device

Device

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

Primary outcomes

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

    Time frame: 48 hours

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Wimms, PhD

CONTACT

[email protected]

61 466015420

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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