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N/A N=109 Randomized Treatment

Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation

Sleep Disordered Breathing · Sleep Apnea · Paroxysmal Atrial Fibrillation

Enrolled (actual)
109
Serious AEs
7.4%
Results posted
Jun 2021
Primary outcome: Primary: Change in AF Burden — 5.6; 5.0; 4.1; 4.3 percentage of time in AF — p=0.520

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
PAP (CPAP or ASV) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oslo University Hospital
Primary completion
Jul 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in AF Burden
5.6; 5.0; 4.5; 4.6 0.410
SECONDARY
Change in AF Burden
5.6; 5.0; 4.5; 4.6 0.410
SECONDARY
Change in AF Burden
5.6; 5.0; 4.5; 4.6 0.410
SECONDARY
Number of Participants With More Than 25% Reduction in AF Burden
22; 17 0.33
SECONDARY
Change of Recurrence Rate After Ablation, as Measured by Loop Recorder
SECONDARY
Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)
SECONDARY
Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
49.9; 52.8; 52.5; 51.5; 43.1; 43.3 0.058
SECONDARY
Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score
8.2; 7.5; 7.1; 7.5 0.110
SECONDARY
Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.
SECONDARY
Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
17.4; 17.7; 17.6; 17.7 0.850
SECONDARY
Change in Symptoms of Sleep Apnea Measured by the STOP-Bang
SECONDARY
Change in CRP
1.2; 1.0; 1.0; 1.1 0.650
SECONDARY
Change in Left Ventricular Ejection Fraction
58.5; 57.9; 59.4; 56.6 0.006 sig
SECONDARY
Change in the Cardiac Marker NT-proBNP.
95.5; 84; 102.5; 87 0.389
SECONDARY
Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.
SECONDARY
Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording
SECONDARY
Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
29.8; 29.8; 29.6; 29.6 0.697
SECONDARY
Lung Function Test as Assessed by Spirometry

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.

Eligibility Criteria

Inclusion Criteria

  • Age 18-75 years
  • Male or female
  • Patients with paroxysmal AF scheduled for first or second catheter ablation
  • Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)
  • Signed informed consent

Exclusion Criteria

  • Unstable patients
  • Patients with left ventricular ejection fraction (LV-EF) 40kg/m2
  • Drowsy drivers and/or sleepy patients with ESS (Epworth Sleepiness Score) > 15
  • Patients with interstitial lung diseases, severe obstructive lung defects, and thoracic myopathies or severe obstructive lung defects with FEV1 < 50% of predicted
  • Oxygen saturation < 90% at rest during the day
  • Poor compliance
  • Patients with single chamber pacemaker (or ICD)
  • Current use of PAP therapy
  • Patients using amiodarone
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02727192). 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.

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