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

Completed

Conditions studied: Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations

In brief

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.

Key facts

Study ID

NCT06907888

Run by

VivaQuant

People needed

30

Starts

2024-11-18

Expected to finish

2025-06-25

Last updated by the study team

2025-07-23

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 21-85 years of age at the time of informed consent.
• Subject has a documented or suspected atrial fibrillation.
• Subject has an indication for 48+ hours of cardiac monitoring due to non-sustained/paroxysmal atrial arrhythmias.
• STOP-BANG ≥ 2.
• Subject has capable cellular service at home.
• 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.
• Life expectancy > 6 months.
• Well-defined and stable diurnal behaviors and nocturnal sleep pattern defined as:
• Subject sets aside ample time to sleep to avoid insufficient sleep.
• Subject does not do shift work (work outside of the traditional 9 to 5 shift).

You may not qualify if…

• Uses short acting nitrates within 3 hours of the sleep study.
• Has a permanent pacemaker or ICD.
• Sustained atrial fibrillation or sustained supraventricular arrhythmias.
• Known congestive heart failure Class ≥ 1 or known LVEF < 45%.
• Active acute pulmonary exacerbation (e.g., pneumonia or bronchitis).
• Known serious respiratory or central nervous system disease that may alter respiratory pattern.
• Currently participating in or plans to participate in another study that could confound the results of this study.
• Cognitive or mental health status that would interfere with study participation and/or proper informed consent.
• Presence of other active medical conditions which could significantly alter pulmonary function.
• Recent (within 28 days) or expected (during study participation) travel over four or more time zones.
• History of opioid usage within the past 30 days.
• Diagnosis of insomnia that is not controlled by medication or other means.
• Currently using CPAP machine.

Where it is running

• Central Arkansas Lung- J&L Research — Conway, Arkansas, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Javara - Tryon Medical Partners, PLLC — Charlotte, North Carolina, United States
• Marshfield Clinic Research Institute — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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