Circadian Rhythm Monitoring Study

NCT07336654 | Not Yet Recruiting

• 1 other identifier: MA250925
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

• 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).

  48 hours

Study Arms (1)

Circadian rhythm monitoring

EXPERIMENTAL

All participants will be provided a wearable non-invasive device which aims to measure circadian rhythm information

Device: Circadian monitoring device

Interventions

Circadian monitoring device DEVICE

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

Circadian rhythm monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ResMed: lead

Central Study Contacts

Alison Wimms, PhD

CONTACT

61 466015420; alison.wimms@resmed.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share