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

Launched by VIVAQUANT · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Rhythm Express Wearable System, which is designed to help detect obstructive sleep apnea (OSA) in adults who may also have a heart condition called atrial fibrillation. The goal is to see how well this wearable device works compared to a traditional sleep study, known as polysomnography (PSG), which is usually done in a sleep center. Participants will wear a small monitor on their chest and a device that checks their blood oxygen levels while they sleep, and then their results will be compared to those from the sleep center study.

To be eligible for this trial, participants need to be between 21 and 85 years old and have been diagnosed with or suspected to have atrial fibrillation. They should also have a reason to monitor their heart activity for at least 48 hours, and be willing to follow the study's instructions. Participants can expect to wear the wearable device for a few days and take part in a sleep study, followed by a phone call to check in after the study. This trial is important because it may provide insights into how effectively the wearable system can monitor sleep apnea, which could lead to better care for patients with these conditions.

Gender

ALL

Eligibility criteria

• Inclusion 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).
• Exclusion Criteria:
• • 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.