Status:
COMPLETED
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
Lead Sponsor:
VivaQuant
Conditions:
Obstructive Sleep Apnea (OSA)
Atrial Fibrillation (Paroxysmal)
Eligibility:
All Genders
21-85 years
Brief 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 particip...
Detailed Description
AF is a chronic, progressive, and debilitating cardiovascular disease that exacerbates other cardiovascular diseases and is a leading cause of morbidity (associated illness) and mortality (death). In ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06907888
Start Date
November 18 2024
End Date
June 25 2025
Last Update
July 23 2025
Active Locations (4)
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1
Central Arkansas Lung- J&L Research
Conway, Arkansas, United States, 72032
2
Clayton Sleep Institute
St Louis, Missouri, United States, 63123
3
Javara - Tryon Medical Partners, PLLC
Charlotte, North Carolina, United States, 28287
4
Marshfield Clinic Research Institute
Marshfield, Wisconsin, United States, 54449