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

NCT06907888 | Completed FDA Device

• 1 other identifier: VIVA-006
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 4

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 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. 1.Complete a Screening Visit to confirm they are eligible to participate in the study.
2. 2.Be trained on the use of the Rhythm Express Wearable System.
3. 3.Wear the RX-1 mini cardiac monitor on their chest for 3-5 days/nights.
4. 4.Wear a pulse oximeter for 2 nights before a scheduled sleep study.
5. 5.Complete a sleep study while wearing the Rhythm Express Wearable System.
6. 6.Complete a telephone follow-up visit 5-10 days after the sleep study.

Conditions

Obstructive Sleep Apnea (OSA); Atrial Fibrillation (Paroxysmal); Palpitations

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Sensitivity and Specificity (AHI>15)

  1 night

• Body Position

  1 night

Study Arms (1)

Rhythm Express Wearable System

Individuals with suspected or observed paroxysmal atrial fibrillation.

Device: Rhythm Express Wearable System

Interventions

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.

Rhythm Express Wearable System

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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: 1. Female subjects (N=9-10; \~30%). 2. Underrepresented minority populations such as African Americans, Asians, Hispanics, etc. (N=6-9; \~20-30%).

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.

Sponsors & Collaborators

• VivaQuant: lead

Study Sites (4)

Central Arkansas Lung- J&L Research

Conway, Arkansas, 72032, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

Javara - Tryon Medical Partners, PLLC

Charlotte, North Carolina, 28287, United States

Location

Marshfield Clinic Research Institute

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Brockway

  VivaQuant

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: November 18, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 25, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (4)