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Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation

NCT06907888 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-07-23

No results posted yet for this study

Summary

The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity. The study involves participants wearing the RX-1 mini cardiac monitor on their chest and a pulse oximeter during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will be evaluated by comparing the results from the Rhythm Express Wearable System with those from the traditional Polysomnography(PSG).

Participants will:

1. Complete a Screening Visit to confirm they are eligible to participate in the study.
2. Be trained on the use of the Rhythm Express Wearable System.
3. Wear the RX-1 mini cardiac monitor on their chest for 3-5 days/nights.
4. Wear a pulse oximeter for 2 nights before a scheduled sleep study.
5. Complete a sleep study while wearing the Rhythm Express Wearable System.
6. Complete a telephone follow-up visit 5-10 days after the sleep study.

Conditions

  • Obstructive Sleep Apnea (OSA)
  • Atrial Fibrillation (Paroxysmal)
  • Palpitations

Interventions

DEVICE

Rhythm Express Wearable System

The Rhythm Express Wearable System consists of the FDA-cleared RX-1 mini Cardiac Monitor, an FDA-cleared pulse oximeter, and a cellular gateway to relay data from the pulse oximeter to the cloud-based RS-1 Server. The RS-1 Sleep Algorithm is a cloud-based software as a medical device (SWMD) that receives inputs from the two FDA-cleared wearable devices. The Algorithm, together with the two wearable devices, comprises the Rhythm Express Wearable System.

Sponsors & Collaborators

  • VivaQuant

    lead INDUSTRY

Principal Investigators

  • Brian Brockway · VivaQuant

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-18
Primary Completion
2025-06-16
Completion
2025-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907888 on ClinicalTrials.gov