N/A
N=86
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Atrial Fibrillation · Arrhythmia · Stroke, Cardiovascular
Bottom Line
View on ClinicalTrials.gov: NCT02743520 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Lifestar Act III (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves) |
2 | — |
| SECONDARY Number of Participants With Frequent Ventricular Premature Contractions |
22 | — |
| SECONDARY Longest Duration of Atrial Fibrillation |
— | — |
| SECONDARY Atrial Fibrillation Episodes Lasting More Than Six Minutes |
— | — |
| SECONDARY The Number of Participants With Frequent Premature Atrial Contractions |
12 | — |
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).
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 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
Data sourced from ClinicalTrials.gov (NCT02743520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.