Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive … (NCT06907888) | Clinical Trial Compass
CompletedNot Applicable
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
United States30 participantsStarted 2024-11-18
Plain-language 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. 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.
Who can participate
Age range21 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. Uses short acting nitrates within 3 hours of the sleep study.