Wearable system for diagnosing sleep apnea in patients with atrial fibrillation

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

This study tests if a new wearable device can accurately detect sleep apnea in adults who have atrial fibrillation by comparing its results to those from a standard sleep study.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 21 Years to 85 Years
• Sex: All
• Sponsor: VivaQuant (Industry-sponsored)
• Locations: 4 sites (Conway, Arkansas and 3 other locations)
• Trial ID: NCT06907888 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the accuracy of the Rhythm Express Wearable System in detecting the severity of obstructive sleep apnea (OSA) in adults with suspected or observed atrial fibrillation. Participants will wear the RX-1 mini cardiac monitor and a pulse oximeter during a traditional sleep study known as polysomnography (PSG). The study will compare the results from the wearable system with those obtained from PSG to confirm the effectiveness of the sleep algorithm used in the device. The study involves a screening visit, training on the device, and follow-up assessments to ensure compliance and monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21-85 with documented or suspected atrial fibrillation and an indication for extended cardiac monitoring.

Not a fit: Patients with sustained atrial fibrillation or those using short-acting nitrates prior to the sleep study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more accessible and accurate method for diagnosing obstructive sleep apnea in patients with atrial fibrillation.

How similar studies have performed: Other studies have shown promise in using wearable technology for sleep apnea diagnosis, but this specific approach is relatively novel.

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.

Where this trial is running

Conway, Arkansas and 3 other locations

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

Study contacts

• Study coordinator: Shivani Guduru

Conditions Obstructive Sleep Apnea; Atrial Fibrillation; Palpitations; RX-1 mini; Rhythm Express Wearable System; VivaQuant