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Completed No phase listed Observational

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

ClinicalTrials.gov ID: NCT06907888

Public ClinicalTrials.gov record NCT06907888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06907888
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
VivaQuant
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 17, 2024
Primary completion
Jun 15, 2025
Completion
Jun 24, 2025
Last update posted
Jul 22, 2025

2024 – 2025

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Central Arkansas Lung- J&L Research Conway Arkansas 72032
Clayton Sleep Institute St Louis Missouri 63123
Javara - Tryon Medical Partners, PLLC Charlotte North Carolina 28287
Marshfield Clinic Research Institute Marshfield Wisconsin 54449

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06907888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2025 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06907888 live on ClinicalTrials.gov.

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