Obstructive Sleep Apnea (OSA)NCT06907888
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
An observational study of Obstructive Sleep Apnea (OSA) and Atrial Fibrillation (Paroxysmal), run by VivaQuant at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- What is being tested?
- Rhythm Express Wearable System
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Nov 2024to 25 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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%).
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Javara - Tryon Medical Partners, PLLC
Charlotte, North Carolina, 28287
Central Arkansas Lung- J&L Research
Conway, Arkansas, 72032
Marshfield Clinic Research Institute
Marshfield, Wisconsin, 54449
Clayton Sleep Institute
St Louis, Missouri, 63123
About this study
Official title: 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
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:
- Complete a Screening Visit to confirm they are eligible to participate in the study.
- Be trained on the use of the Rhythm Express Wearable System.
- Wear the RX-1 mini cardiac monitor on their chest for 3-5 days/nights.
- Wear a pulse oximeter for 2 nights before a scheduled sleep study.
- Complete a sleep study while wearing the Rhythm Express Wearable System.
- Complete a telephone follow-up visit 5-10 days after the sleep study.
Read the 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 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.
- Being tested
- Rhythm Express Wearable System
- Keywords
- Obstructive Sleep Apnea, RX-1 mini, Rhythm Express Wearable System, VivaQuant, Atrial Fibrillation
- Medical subject headings
- Sleep Apnea, Obstructive, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm Express Wearable SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Rhythm Express Wearable System | Individuals with suspected or observed paroxysmal atrial fibrillation. Receives: Device: Rhythm Express Wearable System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity (AHI>5)
Sensitivity and specificity for detecting an apnea-hypopnea index (AHI) >5, when compared to the adjudicated PSG results.
Measured: 1 night
Secondary outcomes (2)
Sensitivity and Specificity (AHI>15)
Sensitivity and Specificity for detecting an apnea-hypopnea index (AHI) >15, when compared to the adjudicated PSG results.
Measured: 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.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start18 Nov 2024
- Primary completion16 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VivaQuant
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Brockway, Study director, VivaQuant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907888
- Sponsor's protocol ID
- VIVA-006
- Status last verified
- Jul 2025
- First submitted
- 26 Mar 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06907888
- Acronym / sponsor ID
- VIVA-006
- Keywords
- Obstructive Sleep Apnea, RX-1 mini, Rhythm Express Wearable System, VivaQuant, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VivaQuantIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Complete a Screening Visit to confirm they are eligible to participate in the study.
- Be trained on the use of the Rhythm Express Wearable System.
- Wear the RX-1 mini cardiac monitor on their chest for 3-5 days/nights.
- Wear a pulse oximeter for 2 nights before a scheduled sleep study.
- Complete a sleep study while wearing the Rhythm Express Wearable System.
- Complete a telephone follow-up visit 5-10 days after the sleep study.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhythm Express Wearable System | – | Device: Rhythm Express Wearable SystemIndividuals with suspected or observed paroxysmal atrial fibrillation. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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%).
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythm Express Wearable SystemThe 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. | Device | Rhythm Express Wearable System |
Primary outcome
Sensitivity and Specificity (AHI>5)
Time frame: 1 night
Sensitivity and specificity for detecting an apnea-hypopnea index (AHI) >5, when compared to the adjudicated PSG results.
2 secondary outcomes
Sensitivity and Specificity (AHI>15)
Time frame: 1 night
Body Position
Time frame: 1 night
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Brockway study director
VivaQuant
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Atrial Fibrillation (Paroxysmal), run by VivaQuant at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (AHI>5) (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.