Circadian Rhythm Monitoring Study

N/ANot Yet RecruitingNCT07336654

ResMed30 enrolled

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Circadian Rhythm

Interventions

Circadian monitoring deviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Association between circadian phase estimated by the wearable device and circadian phase determined by salivary melatonin sampling.

Data taken from melatonin sampling will be compared with data taken from the wearable device to determine the wearables' ability to estimate circadian phase

Time frame: 48 hours

Central Contacts

Alison Wimms, PhD

CONTACT

61 466015420 alison.wimms@resmed.com.au

Data from ClinicalTrials.gov

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