Circadian Rhythm Monitoring Study

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Circadian Rhythm
• Intervention / Treatment: Device: Circadian monitoring device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Wimms, PhD; Phone Number: 61 466015420; Email: alison.wimms@resmed.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Circadian rhythm monitoring; All participants will be provided a wearable non-invasive device which aims to measure circadian rhythm information	Device: Circadian monitoring device; This is a new wearable device for non-invasive continuous monitoring of physiological signals to derive circadian rhythm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ResMed

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MA250925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pilot study to determine feasibility only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No