Circadian Rhythm Monitoring Study

ResMed

Status: Not yet enrolling

Conditions: Circadian Rhythm

Treatments: Device: Circadian monitoring device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07336654

MA250925

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Circadian rhythm monitoring

Experimental group

Description:

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

Treatment:

Device: Circadian monitoring device