Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

University of Miami

Status: Completed

Conditions: Arrhythmia; Atrial Fibrillation; Stroke, Cardiovascular

Treatments: Device: The Lifestar Act III

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02743520

20150860

Details and patient eligibility

About

The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats.

The participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).

Enrollment: 86 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of OSA within the last 12 months
2. No previous diagnosis of atrial fibrillation
3. Able and willing to follow-up as an outpatient
4. Age 40-85 years

Exclusion criteria

1. Life expectancy < 2 years
2. Dementia or other neurologic condition which would make outpatient follow-up difficult
3. CHADS score <2
4. Alcohol or drug abuse which would interfere with outpatient follow-up
5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.
6. Current dialysis treatment or planned treatment within 12 months
7. Known bleeding disorder or prothrombin time >15 seconds
8. Mechanical heart valve requiring anticoagulation
9. Moderate to severe mitral stenosis or regurgitation
10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)
11. Chronic obstructive pulmonary disease with oxygen dependence
12. Pregnant patients or patients that plan to become pregnant within the course of the study*.
13. Patients with anticipated need for a pacemaker during the course of the study *If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Cardiac event monitor

Experimental group

Description:

Participants will under go evaluation with a two week cardiac event monitor.

Treatment:

Device: The Lifestar Act III