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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:
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 addition, AF is the most common cardiac arrhythmia that leads to more hospitalizations than any other arrhythmia. Sleep disorders are also associated with a threefold increased mortality and literature suggests a doubled risk for stroke in people with OSA. Identification of OSA and treatment with CPAP is associated with a reduction in the stroke risk for OSA. Thus, early identification and treatment of AF and OSA may be of major societal benefit in reducing mortality and morbidity.
The Rhythm Express Wearable System consists of the RX-1 mini Cardiac Monitor, a Nonin or Viatom Pulse Oximeter, and an Android Cell Phone with the Rhythm Express Oximetry Application. The RS-1 Sleep Algorithm is a cloud-based software as a medical device (SWMD) that receives inputs from the two FDA-cleared wearable devices. The Algorithm, together with the two wearable devices, comprises the Rhythm Express Wearable System.
This multi-center, prospective, observational, confirmatory study is designed to compare sleep apnea severity classification provided by the RS-1 Sleep Algorithm with Polysomnography (PSG). The proposed research will confirm the accuracy of using the Rhythm Express Wearable System to detect apnea/hypopnea index of at least 5/15/30 in patients with observed or suspected atrial fibrillation by comparing it to data recorded in a PSG, which is considered to be the gold standard for sleep testing. In addition, the ability of the RX-1 mini to detect sleep and assess posture and respiratory rate during sleep will be evaluated.
This initiative represents a significant step towards simplifying the screening process for sleep disorders in people indicated for ambulatory cardiac monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythm Express Wearable System | Individuals with suspected or observed paroxysmal atrial fibrillation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythm Express Wearable System | Device | The Rhythm Express Wearable System consists of the FDA-cleared RX-1 mini Cardiac Monitor, an FDA-cleared pulse oximeter, and a cellular gateway to relay data from the pulse oximeter to the cloud-based RS-1 Server. The RS-1 Sleep Algorithm is a cloud-based software as a medical device (SWMD) that receives inputs from the two FDA-cleared wearable devices. The Algorithm, together with the two wearable devices, comprises the Rhythm Express Wearable System. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity (AHI>5) | Sensitivity and specificity for detecting an apnea-hypopnea index (AHI) >5, when compared to the adjudicated PSG results. | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity (AHI>15) | Sensitivity and Specificity for detecting an apnea-hypopnea index (AHI) >15, when compared to the adjudicated PSG results. | 1 night |
| Body Position | Body position of sleeping subject as measured by the percentage of instances where at least one of the estimated directions in the pair (e.g., LeftSupine) matches the PSG adjudication. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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The study population will include up to 30 adults (21 to 85 years of age, inclusive) with observed or suspected atrial fibrillation who are indicated for ambulatory cardiac monitoring. Enrollment strategies will aim to target the following populations to ensure proper representation of the following underrepresented populations:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Brockway | VivaQuant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Lung- J&L Research | Conway | Arkansas | 72032 | United States | ||
| Clayton Sleep Institute |
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|
| 1 night |
| St Louis |
| Missouri |
| 63123 |
| United States |
| Javara - Tryon Medical Partners, PLLC | Charlotte | North Carolina | 28287 | United States |
| Marshfield Clinic Research Institute | Marshfield | Wisconsin | 54449 | United States |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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