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Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS) (ADIOS)

Primary Purpose

Atrial Fibrillation, Arrhythmia, Stroke, Cardiovascular

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Lifestar Act III
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring sleep apnea, arrhythmia detection

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac event monitor

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Frequent Ventricular Premature Contractions
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
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.
Atrial Fibrillation Episodes Lasting More Than Six Minutes
In participants with atrial fibrillation as evaluated by the LifestarAct III.
The Number of Participants With Frequent Premature Atrial Contractions
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.

Full Information

First Posted
April 14, 2016
Last Updated
October 30, 2020
Sponsor
University of Miami
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02743520
Brief Title
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Acronym
ADIOS
Official Title
Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
April 3, 2019 (Actual)
Study Completion Date
April 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrhythmia, Stroke, Cardiovascular
Keywords
sleep apnea, arrhythmia detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac event monitor
Arm Type
Experimental
Arm Description
Participants will under go evaluation with a two week cardiac event monitor.
Intervention Type
Device
Intervention Name(s)
The Lifestar Act III
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)
Description
New cases of atrial fibrillation as evaluated by the LifestarAct III.
Time Frame
Week 2
Secondary Outcome Measure Information:
Title
Number of Participants With Frequent Ventricular Premature Contractions
Description
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Time Frame
week 2
Title
Longest Duration of Atrial Fibrillation
Description
Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.
Time Frame
Week 2
Title
Atrial Fibrillation Episodes Lasting More Than Six Minutes
Description
In participants with atrial fibrillation as evaluated by the LifestarAct III.
Time Frame
Week 2
Title
The Number of Participants With Frequent Premature Atrial Contractions
Description
More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.
Time Frame
Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto R Ramos, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

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