Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in AF Burden |
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. |
Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period. |
|
Secondary |
Change in AF Burden |
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. |
Baseline to the last month of intervention period |
|
Secondary |
Change in AF Burden |
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). |
Comparing Baseline to the last five months of the intervention period |
|
Secondary |
Number of Participants With More Than 25% Reduction in AF Burden |
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. |
Baseline to last three months of the intervention |
|
Secondary |
Change of Recurrence Rate After Ablation, as Measured by Loop Recorder |
Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation. |
12 months |
|
Secondary |
Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS) |
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). |
6 months, 12 months and 18 months |
|
Secondary |
Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) |
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. |
Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported. |
|
Secondary |
Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score |
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) |
6 months, 12 months and 18 months. Baseline and 6 months reported |
|
Secondary |
Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire. |
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. |
6 months, 12 months and 18 months |
|
Secondary |
Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) |
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. |
6 months, 12 months and 18 months. Baseline and 6 months reported. |
|
Secondary |
Change in Symptoms of Sleep Apnea Measured by the STOP-Bang |
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. |
6 months, 12 months and 18 months |
|
Secondary |
Change in CRP |
Difference between PAP treatment and usual care in change of CRP |
6 months, 12 months and 18 months. Baseline and 6 months reported. |
|
Secondary |
Change in Left Ventricular Ejection Fraction |
Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco |
6 months, 12 months and 18 months. Baseline and 6 months reported. |
|
Secondary |
Change in the Cardiac Marker NT-proBNP. |
Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP. |
6 months, 12 months. Baseline and 6 months reported. |
|
Secondary |
Examine the Effect of SA Treatment on Gene Expression of White Blood Cells. |
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 |
6 months and 12 months |
|
Secondary |
Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording |
Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording |
6 months and 12 months |
|
Secondary |
Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) |
Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita) |
Baseline to follow up 6 months |
|
Secondary |
Lung Function Test as Assessed by Spirometry |
Lung function test as assessed by spirometry |
Baseline, 6 months |
|