NCT02743520: ADIOS

Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)

Completed NA Results posted Last updated 19 November 2020

What this trial tests

NA trial testing The Lifestar Act III in Atrial Fibrillation in 86 participants. Completed in 3 April 2019.

Timeline

6 March 2017

Primary endpoint
3 April 2019

3 April 2019

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	86
Start date	6 March 2017
Primary completion	3 April 2019
Estimated completion	3 April 2019
Sites	1 location across United States

Drugs / interventions tested

• The Lifestar Act III

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Arrhythmia — all drugs for Arrhythmia →
• Stroke, Cardiovascular — all drugs for Stroke, Cardiovascular →

Sponsor

University of Miami

Who can join

Adults 40 to 85, any sex, with Atrial Fibrillation or Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) Primary · Week 2

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

Group	Value	95% CI
Cardiac Event Monitor	2

Number of Participants With Frequent Ventricular Premature Contractions Secondary · week 2

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

Group	Value	95% CI
Cardiac Event Monitor	22

The Number of Participants With Frequent Premature Atrial Contractions Secondary · Week 2

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

Group	Value	95% CI
Cardiac Event Monitor	12

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Interplay between Obstructive Sleep Apnea and Atrial Fibrillation.
   Marulanda-Londoño E, Chaturvedi S. · · 2017 · cited 64× · PMID 29312113 · DOI 10.3389/fneur.2017.00668