Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arrhythmia; Stroke, Cardiovascular
• Interventions: Device: The Lifestar Act III

• Registration Number: NCT02743520
• Lead Sponsor: University of Miami

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-19
• Study Start: 2017-03-06
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-03
• Status Verified: 2020-10
• Results First Submitted: 2020-10-06
• Results First Submitted QC: 2020-10-30
• Last Update Submitted: 2020-10-30
• Results First Posted: 2020-11-19
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac event monitor	The Lifestar Act III	Participants will under go evaluation with a two week cardiac event monitor.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)	Week 2	New cases of atrial fibrillation as evaluated by the LifestarAct III.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States