Clinical trial NCT02743520: Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Official title: Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmia
Stroke, Cardiovascular
Keywords: sleep apnea
arrhythmia detection
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2016-04-19
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
timeFrame: Week 2
Secondary outcomes:
measure: Number of Participants With Frequent Ventricular Premature Contractions
timeFrame: week 2
measure: Longest Duration of Atrial Fibrillation
timeFrame: Week 2
measure: Atrial Fibrillation Episodes Lasting More Than Six Minutes
timeFrame: Week 2
measure: The Number of Participants With Frequent Premature Atrial Contractions
timeFrame: Week 2
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Alberto R Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References: