NCT06907888Completed
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2025
Brief summary (registry, in English)
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. Complete a Screening Visit to confirm they are eligible to participate in the study. 2. Be trained on the use of the Rhythm Express Wearable System. 3. Wear the RX-1 mini cardiac monitor on their chest for 3-5 days/nights. 4. Wear a pulse oximeter for 2 nights before a scheduled sleep study. 5. Complete a sleep study while wearing the Rhythm Express Wearable System. 6. Complete a telephone follow-up visit 5-10 days after the sleep study.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 26 Mar 2025
- Start date
- 18 Nov 2024
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- VivaQuant
- Diseases
- Atrial fibrillation
- NCT number
- NCT06907888
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 18 Nov 2024 to the primary completion date, 16 Jun 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of insomnia that is not controlled by medication or other means.
- Currently using CPAP machine.
Other illness
- Sustained atrial fibrillation or sustained supraventricular arrhythmias.
- Known serious respiratory or central nervous system disease that may alter respiratory pattern.
- Presence of other active medical conditions which could significantly alter pulmonary function.
- History of opioid usage within the past 30 days.
Lab values
- Known congestive heart failure Class ≥ 1 or known LVEF \< 45%.
Other
- Uses short acting nitrates within 3 hours of the sleep study.
- Has a permanent pacemaker or ICD.
- Active acute pulmonary exacerbation (e.g., pneumonia or bronchitis).
- 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.
- Recent (within 28 days) or expected (during study participation) travel over four or more time zones.
Who the study is looking for
- 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).
Age in the registry: 21 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Javara - Tryon Medical Partners, PLLC Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Central Arkansas Lung- J&L Research Coordinator of this site? Confirm its status | Conway | United States | Unknown status |
| Marshfield Clinic Research Institute Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Clayton Sleep Institute Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.