Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

Study Overview
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Brief Summary
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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).

Official Title
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Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea

Conditions
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Arrhythmia, Atrial Fibrillation, Stroke, Cardiovascular

Intervention / Treatment
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* Device: The Lifestar Act III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of OSA within the last 12 months No previous diagnosis of atrial fibrillation Able and willing to follow-up as an outpatient Age 40-85 years Exclusion Criteria: Life expectancy < 2 years Dementia or other neurologic condition which would make outpatient follow-up difficult CHADS score <2 Alcohol or drug abuse which would interfere with outpatient follow-up Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device. Current dialysis treatment or planned treatment within 12 months Known bleeding disorder or prothrombin time >15 seconds Mechanical heart valve requiring anticoagulation Moderate to severe mitral stenosis or regurgitation Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded) Chronic obstructive pulmonary disease with oxygen dependence Pregnant patients or patients that plan to become pregnant within the course of the study*. 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac event monitor<br>Participants will under go evaluation with a two week cardiac event monitor. | Device: The Lifestar Act III<br>* The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) | New cases of atrial fibrillation as evaluated by the LifestarAct III. | Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Frequent Ventricular Premature Contractions | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. | week 2 | 
| Longest Duration of Atrial Fibrillation | Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III. | Week 2 | 
| Atrial Fibrillation Episodes Lasting More Than Six Minutes | In participants with atrial fibrillation as evaluated by the LifestarAct III. | Week 2 | 
| The Number of Participants With Frequent Premature Atrial Contractions | More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III. | Week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, arrhythmia detection