RX-1 Sleep
RX-1 Sleep
Evaluate Sleep Apnea and
Help Assess AF Burden in One Test
ONE TEST, TWO CLINICALLY TIED CONDITIONS
RX-1 Sleep, featuring RX-1 mini, brings cardiac rhythm monitoring and sleep-related breathing assessment together in a connected platform. By combining the FDA-cleared RX-1 mini cardiac monitor with compatible pulse oximetry and sleep-analysis software, the platform helps clinicians evaluate sleep-disordered breathing in adults suspected of having sleep apnea while providing cardiac information to aid in the assessment of arrhythmia activity and AF burden.
Patients may undergo up to three nights of sleep assessment alongside cardiac monitoring lasting up to 30 days, as prescribed by their healthcare professional.
CARDIAC + OXYGEN DATA
Combines ECG and heart-rhythm information with overnight SpO₂ monitoring in one report.
MULTI-NIGHT ASSESSMENT
Supports evaluation across multiple nights for a broader view of sleep-disordered breathing.
CONNECTED DATA FLOW
Cellular, Wi-Fi and Bluetooth connectivity help move monitoring data through the connected workflow.
SYNCHRONIZED SIGNALS
Brings cardiac, oxygen-saturation and activity data together in one coordinated dataset.
MORE THAN AHI
Measures AHI while also evaluating sleep/wake, posture and respiratory effort.
CONSOLIDATED CLINICAL REVIEW
Brings RX-1 Sleep outputs and full-disclosure signals together for healthcare professional review.
AF AND SLEEP APNEA OFTEN TRAVEL TOGETHER, BUT THEIR DIAGNOSTIC PATHWAYS DON’T
1 Sleep apnea and atrial fibrillation: challenges in clinical and translational research. B. Linz, J. N. Hertel, J. Hendriks, A. Saljic, D. Dobrev, M. Baumert, T. Jespersen, D. Linz, Expert Review of Cardiovascular Therapy. Volume 20, Issue 2, February 2022, Pages 101–109.
2 Atrial Fibrillation And Sleep Apnea: Considerations For A Dual Epidemic. P. Tung, E. Anter, Journal of Atrial Fibrillation. Volume 8, Issue 6, April–May 2016, Article 1283.
3 The epidemiology of obstructive sleep apnoea and cardiovascular disease. P. Sarkar, S. Mukherjee, C. L. Chai-Coetzer, R. D. McEvoy, Journal of Thoracic Disease. Volume 10, Supplement 34, December 2018, Pages S4189–S4200.
RX-1 SLEEP: SIMULTANEOUS CARDIAC AND SLEEP INSIGHTS
A DIFFERENT KIND OF HOME SLEEP TEST
EXTENDED CARDIAC MONITORING
See more than AF presence: Extended ECG monitoring with RX-1 mini provides cardiac rhythm information to aid clinicians in assessing AF burden across the prescribed monitoring period—not just during sleep assessment.
MULTI-NIGHT SLEEP ASSESSMENT
Go beyond a single night: Support the evaluation of sleep-disordered breathing for up to three nights, providing information about night-to-night variability in sleep-related findings.
SYNCHRONIZED DATA
Simultaneously connect cardiac rhythm and sleep: Bring ECG and oximetry data together within the same diagnostic period for a more connected clinical picture.
PATIENT-FRIENDLY DESIGN
Designed for life at home: Compact cardiac monitoring and wrist-worn pulse oximetry create a streamlined at-home testing experience.
VALIDATED PERFORMANCE ACROSS THE MEASURES THAT MATTER
Validated against 476 polysomnography studies, RX-1 Sleep demonstrated consistently strong diagnostic performance across mild, moderate and severe sleep apnea thresholds.
In a comparative review of commonly used home sleep apnea testing technologies, RX-1 Sleep ranked atop reported diagnostic accuracy measures while adding the ability to assess AF burden through extended cardiac rhythm monitoring.
NEW RESEARCH:
SEE HOW RX-1 SLEEP PERFORMS
Review new research examining RX-1 Sleep's performance in assessing sleep-related breathing disorders and explore the role of connected cardiac and sleep information in clinical evaluation.
This publication was funded, sponsored and prepared by VivaQuant, Inc., doing business as Rhythm Express.
MODELS TO FIT YOUR NEEDS
Rhythm Express offers multiple service models so practices can align monitoring with patient volume, operational preferences and billing approach.
VALUE ACROSS THE CARE EXPERIENCE
- Support cardiac monitoring and evaluation of suspected sleep apnea within a coordinated monitoring workflow.
- Simplify ordering, data collection and clinical review when both evaluations are prescribed.
- Reduce the need for separate monitoring equipment and duplicative patient setup steps.
- Access cardiac rhythm information from RX-1 mini to aid in the assessment of arrhythmia activity and AF burden.
- Review sleep-related findings alongside cardiac monitoring information to support informed clinical evaluation.
- Gather sleep-related information across multiple nights to provide additional context for healthcare professional review.
Frequently Asked Questions
What is RX-1 Sleep?
RX-1 Sleep is FDA-cleared software designed to aid healthcare professionals in evaluating sleep-related breathing disorders in adults suspected of having sleep apnea. It uses data from the FDA-cleared RX-1 mini cardiac monitoring system and a compatible pulse oximeter. When prescribed together, these technologies support cardiac monitoring and sleep assessment during the same monitoring period, with related information available for healthcare professional review.
Who is RX-1 Sleep intended for?
RX-1 Sleep is intended for adults suspected of having sleep apnea and is used under the direction of a healthcare professional. RX-1 mini has separate indications for patients who have, are at risk of having, or exhibit intermittent symptoms indicative of cardiac disease requiring ongoing cardiac monitoring. A healthcare professional determines whether one or both evaluations are appropriate.
What modalities do you track?
RX-1 Sleep analyzes inputs from RX-1 mini and compatible pulse oximetry to provide sleep-related outputs, including AHI, sleep/wake, posture and respiratory effort.
The connected platform can also present pulse oximetry information and cardiac data from RX-1 mini, including heart rate and arrhythmia activity, for healthcare professional review. RX-1 mini cardiac information can aid clinicians in assessing arrhythmia activity and AF burden.
How does RX-1 Sleep work?
In addition to wearing the RX-1 mini, patients will wear a comfortable pulse oximeter on their finger while they sleep. The pulse oximeter communicates with the RX-1 mini to automatically send information to Rhythm Express’ monitoring centers in Memphis and Dallas where it is analyzed using an advanced algorithm. Once the recording has been completed, a specialized technician (a certified cardiac rhythm technologist) summarizes the arrhythmia findings and a second specialized technician (a certified sleep technologist) creates summary reports and posts them on a secure portal for health care providers to review. The HCPs will then use this information as an aid in their diagnosis.
How do providers access the portal?
Accessing patient data is simple and secure with our intuitive web portal. Providers can follow these steps:
- Your Rhythm Express team will send you a direct link
- Enter your unique provider credentials
- Navigate to the patient dashboard for available monitoring data and comprehensive reports
For additional portal support or to set up your account, contact Rhythm Express’ dedicated provider support team at 866-324-8783.
How does Rhythm Express provide patient reports?
Rhythm Express prioritizes prompt delivery of actionable information. Typically, event notifications are available within 20 minutes, and summary reports are delivered not long after the monitoring period’s completion. Our commitment to rapid reporting empowers clinicians to make timely, informed decisions for patient care.
How does Rhythm Express ensure data security and HIPAA compliance?
Rhythm Express takes data security and patient privacy seriously. The RX-1 Sleep uses NSA-level encryption for data transmission, and our secure cloud-based infrastructure adheres to stringent HIPAA guidelines. We conduct regular security audits, vulnerability scanning, and ongoing staff training to ensure that we maintain the highest standards of data protection and compliance. We also partner with industry-leading Managed Detection and Response (MDR), Cloud Provider and Firewall services to provide 24/7/365 monitoring of our cloud-based systems and event response.
Can RX-1 Sleep integrate with common Electronic Health Record (EHR) systems?
Rhythm Express partners with a prominent third-party EHR integrator, which has executed over 9,000 integrations across 90+ EHRs and 50+ HIEs & HINs. Our team works closely with IT departments to ensure smooth data flow, reducing administrative burden and enhancing workflow efficiency.
What kind of training and support does Rhythm Express offer clinical staffs?
Rhythm Express provides comprehensive training and ongoing support to ensure care teams can fully leverage the RX-1 Sleep system. This includes:
- Initial on-site or virtual training sessions
- Access to guides
- 24/7/365 technical support via phone and email
How does Rhythm Express handle patient education and support?
Rhythm Express provides comprehensive patient education materials, including easy-to-understand setup guides in English and in Spanish. Our patient support team is available 24/7/365 to assist with questions or concerns and has the capability to assist callers in over 300 different languages.
How are device malfunctions or replacements handled?
In the rare event of a device malfunction, Rhythm Express’ support team is available 24/7/365 to troubleshoot issues. If a replacement is needed, we expedite shipping to minimize monitoring interruptions. Our flexible inventory management ensures that providers always have backup devices on hand for immediate patient use.
Can the monitoring duration be customized to individual patients?
Yes. RX-1 Sleep supports multi-night sleep assessment, allowing clinicians to evaluate sleep-disordered breathing over more than a single night when appropriate. This can provide a broader view of night-to-night variability while pairing sleep findings with cardiac rhythm information.
What certifications and regulatory approvals does the RX-1 Sleep have?
RX-1 Sleep and RX-1 mini are both FDA-cleared technologies, each with distinct indications for use.
RX-1 Sleep (FDA 510(k) K253148) is cleared to aid in the evaluation of sleep-related breathing disorders in adults suspected of having sleep apnea. The software analyzes data from two FDA-cleared devices, the RX-1 mini and a compatible Viatom pulse oximeter, which present findings for healthcare professional review.
RX-1 mini (FDA 510(k) K241179) is cleared for ongoing cardiac monitoring in patients who have or are at risk of having cardiac disease, or who exhibit intermittent symptoms indicative of cardiac disease. It continuously records ECG data and transmits cardiac information for professional review. It does not provide independent diagnostic interpretations or function as a real-time arrhythmia alarm system.
Rhythm Express is also certified under the Medical Device Single Audit Program (MDSAP), which incorporates ISO 13485 quality management system requirements and supports high standards in medical device manufacturing and service delivery. Both technologies are intended for use under the direction of a healthcare professional.
BRING RX-1 SLEEP TO YOUR PRACTICE
Bring cardiac rhythm monitoring and sleep-disordered breathing aided assessment together in one simultaneous diagnostic experience. Connect with Rhythm Express to learn how RX-1 Sleep can fit into your practice, workflow and patient care.
