CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
PAP (CPAP or ASV)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02727192
NCT02727192N/ACompleted

Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation

Oslo University Hospital·interventional·Posted Apr 4, 2016·Updated Jun 22, 2021

In Brief

A clinical study evaluating PAP (CPAP or ASV) for Sleep Disordered Breathing and 2 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed Summary

Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Unfortunately treatment options remain limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential for toxicity and adverse events are recognized. Recent year's catheter ablation of AF continues to gain acceptance for symptomatic treatment, but recurrence rate are high with need for continuous medication. Thus there is a need to better understand what causes development and triggers episodes of AF as well to introduce new treatment options. Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore gained interest. Many patients with AF have chronic sleep apnea, and in the present study the investigators want to explore the interaction between SA and AF. The hypothesis of the present study is that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis the investigators will implant a Reveal device that continuously records the hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be examined, and the patients will then be randomized to treatment of SA or not and the influence on total AF burden recorded both before and after ablation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNorway

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 4, 2016
Enrollment StartJan 21, 2016
Primary CompletionJul 1, 2019
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

PAP (CPAP or ASV)device

Patients will be randomized to treatment of Sleep Apnea with a CPAP or control