Circadian Rhythm Monitoring Study

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07336654

Enrollment

Registered

2026-01-13

Start date

2026-07-01

Completion date

2026-12-01

Last updated

2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm

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

Interventions

DEVICECircadian monitoring device

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of estimating circadian phase with the myCircadian wearable device. Correlation	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).

Contacts

CONTACTAlison Wimms, PhD

alison.wimms@resmed.com.au61 466015420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026