Trial Outcomes & Findings for Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation (NCT NCT02727192)

109 patients with paroxysmal atrial fibrillation and moderate to severe sleep apnea were included in the study and randomized to PAP-therapy or control. One patient refused further participation and was not included in the analysis. 108 patients were therefore included in the full set analysis. 21 patients without sleep apnea or mild sleep apnea (AHI\<15) were included as a reference group. Therefore, 130 patients were included in the study, but only 109 were included for randomization.

Before inclusion patients were invited to a CPAP mask tolerance test. Patients who complied with the treatment were invited to be included in the study. All patients were randomized to CPAP. In the CPAP group, one patient had CPAP treatment-emergent central SA shortly after randomization and was therefore switched to ASV.

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

Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the five month intervention period.

Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last month of the intervention period.

Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last five months of the intervention period (the whole intervention period).

Difference between PAP treatment and usual care in the proportion of patients with at least 25% reduction of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the intervention period.

Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.

Change in AF symptoms between CPAP treatment and usual care. The questionnaire quantifies three domains of AF: event frequency (score 1-10), duration (score 1-10), and global episode severity (score 1-10). The total AF burden is calculated from the modified sum of the frequency, duration, and severity of AF (score 3-30, with higher scores indicating greater AF burden ). In addition, the AFSS assesses a symptom score based on seven items asking how bothered patients are by specified symptoms (score 0-35). Global well-being is a visual analogue scale ranging from 1 to 10 (10 indicating the best possible life).

Difference between CPAP and usual care in QoL as assessed by SF36, Version 1.2. Item scores are transformed into the Physical and Mental Component Summary scores (PCS and MCS). Scores range from 0 to 100, with higher scores indicating a better health state.

Difference between PAP treatment and usual care in Change in daytime sleepiness as measured using the Epworth Sleepiness Scale (ESS) score, with scores ranging from 0 to 24 (most sleepy)

Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Berlin Questionnaire. Positive scores in two or more categories suggest a high risk of OSA.

Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Functional Outcomes of Sleep Questionnaire (FOSQ). Score range is 5-20 Points, with higher scores indicating better functional status.

Change in sleep quality and symptoms of obstructive sleep apnea as measured using the STOP-Bang Questionnaire. Score between 0-8. A score of ≥3 suggest risk for OSA.

Difference between PAP treatment and usual care in change of CRP

Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco

Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.

Examine the effect of SA treatment on gene Expression of white blood cells. Is paroxysmal AF Associated with specific gene Expression patterns? Examine the influence of SA treatment on the pattern of gene Expression and if this is related to reduction of atrial fibrillation burden

Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording

Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)

Lung function test as assessed by spirometry