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

Description

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

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Study Overview

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Study Details

Study overview

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.

A Confirmatory Study to Evaluate the Rhythm Express Wearable System vs. Simultaneous Polysomnography (PSG) for the Diagnosis of Obstructive Sleep Apnea in an Adult Population With Observed or Suspected Atrial Fibrillation, and Are Indicated for Ambulatory Cardiac Monitoring

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

Condition
Obstructive Sleep Apnea (OSA)
Intervention / Treatment

-

Contacts and Locations

Conway

Central Arkansas Lung- J&L Research, Conway, Arkansas, United States, 72032

St Louis

Clayton Sleep Institute, St Louis, Missouri, United States, 63123

Humble

Modern Heart and Vascular Institute, Humble, Texas, United States, 77338

Marshfield

Marshfield Clinic Research Institute, Marshfield, Wisconsin, United States, 54449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or female between 21-85 years of age at the time of informed consent.
  • 2. Subject has a documented or suspected atrial fibrillation.
  • 3. Subject has an indication for 48+ hours of cardiac monitoring due to non-sustained/paroxysmal atrial arrhythmias.
  • 4. STOP-BANG ≥ 2.
  • 5. Subject has capable cellular service at home.
  • 6. Willingness and ability to comply with the study protocol, including informed consent, all study visits, and the collection of adverse events at the telephone follow-up visit.
  • 7. Life expectancy \> 6 months.
  • 8. Well-defined and stable diurnal behaviors and nocturnal sleep pattern defined as:
  • 1. Subject sets aside ample time to sleep to avoid insufficient sleep.
  • 2. Subject does not do shift work (work outside of the traditional 9 to 5 shift).
  • 1. Uses short acting nitrates within 3 hours of the sleep study.
  • 2. Has a permanent pacemaker or ICD.
  • 3. Sustained atrial fibrillation or sustained supraventricular arrhythmias.
  • 4. Known congestive heart failure Class ≥ 1 or known LVEF \< 45%.
  • 5. Active acute pulmonary exacerbation (e.g., pneumonia or bronchitis).
  • 6. Known serious respiratory or central nervous system disease that may alter respiratory pattern.
  • 7. Currently participating in or plans to participate in another study that could confound the results of this study.
  • 8. Cognitive or mental health status that would interfere with study participation and/or proper informed consent.
  • 9. Presence of other active medical conditions which could significantly alter pulmonary function.
  • 10. Recent (within 28 days) or expected (during study participation) travel over four or more time zones.
  • 11. History of opioid usage within the past 30 days.
  • 12. Diagnosis of insomnia that is not controlled by medication or other means.
  • 13. Currently using CPAP machine.

Ages Eligible for Study

21 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VivaQuant,

Brian Brockway, STUDY_DIRECTOR, VivaQuant

Study Record Dates

2025-05