Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

Atrial Fibrillation Clinical Trial

— ADIOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743520
• Other study ID #: 20150860
• Status: Completed
• Phase: N/A
• Start date: March 6, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: October 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 3, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Fibrillation
• Myocardial Infarction
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke, Cardiovascular

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Atrial Fibrillation Episodes Lasting More Than Six Minutes	In participants with atrial fibrillation as evaluated by the LifestarAct III.	Week 2
Secondary	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