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

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

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).

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmia; Stroke, Cardiovascular
• Intervention / Treatment: Device: The Lifestar Act III

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac event monitor; Participants will under go evaluation with a two week cardiac event monitor.	Device: The Lifestar Act III; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Alberto R Ramos, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): April 3, 2019
• Study Completion (Actual): April 3, 2019

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimate): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: sleep apnea; arrhythmia detection
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Infarction; Myocardial Infarction; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 20150860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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