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Completed

NCT Number: NCT02743520

Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

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).

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Key information

Conditions

Atrial Fibrillation Apnea Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Dyssomnias Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke, Cardiovascular Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Lifestar Act III

Device

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 outcomes

  1. Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)

    Time frame: Week 2

    New cases of atrial fibrillation as evaluated by the LifestarAct III.

Secondary outcomes

  1. Number of Participants With Frequent Ventricular Premature Contractions

    Time frame: week 2

    More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.

  2. Longest Duration of Atrial Fibrillation

    Time frame: 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.

  3. Atrial Fibrillation Episodes Lasting More Than Six Minutes

    Time frame: Week 2

    In participants with atrial fibrillation as evaluated by the LifestarAct III.

  4. The Number of Participants With Frequent Premature Atrial Contractions

    Time frame: Week 2

    More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Acronym: ADIOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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