Paroxysmal Atrial Fibrillation, Sleep Apnea, Sleep Disordered Breathing
Conditions
Keywords
Atrial fibrillation, CPAP, Sleep apnea, Sleep disordered breathing
Brief 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.
Detailed description
For the present project the investigators have established a research team from 2 different university hospitals. This team, including high ranked, internationally renowned scientist from both clinical and basic sciences, will make a framework for PhD candidates and will ensure the patient cohort. Patients with paroxysmal AF and SA will be examined with an extensive diagnostic battery including advanced cardiac imaging tools allowing a proper description of the heart. Then a Reveal that continuously monitor the rhythm of the heart will be inserted, allowing the influence of SA, physical activity, inflammatory parameters, and other external variables on total AF burden to be examined. The patients will then be randomized to treatment of SA with a CPAP or not, and the AF burden recorded 6 months before ablation and 6 months after. The present investigations carried out, are expected to results in better understanding of the interaction between AF and SA and may lay the scientific basis for better diagnostic and therapeutic approaches for patients with AF. In addition, given the advantage of continuous Reveal® recording of the patient's heart rhythm, the present study will examine possible triggers of AF such as activity level and inflammatory substances, and examine the role of structural abnormalities in the heart as assessed by echocardiography for the triggering of AF episodes. An overall aim is therefore a better phenotyping of the patient which could aid in a more person-specific treatment approach, with direct consequences both for the individual patient and for the society.
Interventions
DEVICEPAP (CPAP or ASV)
Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
Sponsors
Norwegian Health Association
Medtronic
ResMed
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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) \< 45% * Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study * Bypass surgery within 6 months prior to the study * Patients with TIA or stroke within the previous 3 months * BMI \> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AF Burden | Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months 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 three months of the five month intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in AF Burden | Baseline to the last month of 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. |
| Number of Participants With More Than 25% Reduction in AF Burden | Baseline to last three months of the intervention | 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 | 12 months | 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 as Assessed by Atrial Fibrillation Severity Scale (AFSS) | 6 months, 12 months and 18 months | 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). |
| Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported. | 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. |
| Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score | 6 months, 12 months and 18 months. Baseline and 6 months reported | 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 Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire. | 6 months, 12 months and 18 months | 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. |
| Lung Function Test as Assessed by Spirometry | Baseline, 6 months | Lung function test as assessed by spirometry |
| Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | 6 months, 12 months and 18 months. Baseline and 6 months reported. | 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 Symptoms of Sleep Apnea Measured by the STOP-Bang | 6 months, 12 months and 18 months | 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. |
| Change in CRP | 6 months, 12 months and 18 months. Baseline and 6 months reported. | Difference between PAP treatment and usual care in change of CRP |
| Change in Left Ventricular Ejection Fraction | 6 months, 12 months and 18 months. Baseline and 6 months reported. | Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco |
| Change in the Cardiac Marker NT-proBNP. | 6 months, 12 months. Baseline and 6 months reported. | 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. | 6 months and 12 months | 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 | 6 months and 12 months | Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording |
| Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) | Baseline to follow up 6 months | Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita) |
Countries
Norway
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PAP-therapy (CPAP or ASV) PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV). | 54 |
| Control Group No sleep apnea treatment (usual care) | 54 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | PAP-therapy (CPAP or ASV) | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 7.4 | 62.1 years STANDARD_DEVIATION 7.8 | 62.6 years STANDARD_DEVIATION 7.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 54 Participants | 108 Participants |
| Region of Enrollment Norway | 54 Participants | 54 Participants | 108 Participants |
| Sex: Female, Male Female | 15 Participants | 11 Participants | 26 Participants |
| Sex: Female, Male Male | 39 Participants | 43 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 54 | 0 / 1 |
| other Total, other adverse events | 0 / 53 | 0 / 54 | 0 / 1 |
| serious Total, serious adverse events | 6 / 53 | 2 / 54 | 0 / 1 |
Outcome results
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.
Time frame: Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in AF Burden | Baseline | 5.6 percentage of time in AF | Standard Deviation 8.3 |
| PAP-therapy (CPAP or ASV) | Change in AF Burden | Last three months of intervention | 4.1 percentage of time in AF | Standard Deviation 6.5 |
| Control Group | Change in AF Burden | Baseline | 5.0 percentage of time in AF | Standard Deviation 8.9 |
| Control Group | Change in AF Burden | Last three months of intervention | 4.3 percentage of time in AF | Standard Deviation 9.4 |
p-value: 0.5295% CI: [-2.6, 1.3]Regression, Linear
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).
Time frame: Comparing Baseline to the last five months of the intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in AF Burden | Baseline | 5.6 percentage of time in AF | Standard Deviation 8.3 |
| PAP-therapy (CPAP or ASV) | Change in AF Burden | 5 months intervention period | 4.5 percentage of time in AF | Standard Deviation 6.4 |
| Control Group | Change in AF Burden | Baseline | 5.0 percentage of time in AF | Standard Deviation 8.9 |
| Control Group | Change in AF Burden | 5 months intervention period | 4.6 percentage of time in AF | Standard Deviation 9.8 |
p-value: 0.4195% CI: [-2.1, 0.9]Regression, Linear
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.
Time frame: Baseline to the last month of intervention period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in AF Burden | Last month of the intervention period | 4.6 percentage of time in AF | Standard Deviation 8.1 |
| PAP-therapy (CPAP or ASV) | Change in AF Burden | Baseline | 5.6 percentage of time in AF | Standard Deviation 8.3 |
| Control Group | Change in AF Burden | Baseline | 5.0 percentage of time in AF | Standard Deviation 8.9 |
| Control Group | Change in AF Burden | Last month of the intervention period | 5.1 percentage of time in AF | Standard Deviation 10.8 |
p-value: 0.4495% CI: [-3.3, 1.5]Regression, Linear
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).
Time frame: 6 months, 12 months and 18 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)
Time frame: Baseline to follow up 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) | Baseline | 29.8 Kg/m ̂ 2 | Standard Deviation 4.8 |
| PAP-therapy (CPAP or ASV) | Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) | Follow up 6 months | 29.6 Kg/m ̂ 2 | Standard Deviation 5.1 |
| Control Group | Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) | Baseline | 29.8 Kg/m ̂ 2 | Standard Deviation 4.1 |
| Control Group | Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) | Follow up 6 months | 29.6 Kg/m ̂ 2 | Standard Deviation 4.2 |
p-value: 0.69795% CI: [-0.3, 0.5]Regression, Logistic
Secondary
Change in CRP
Difference between PAP treatment and usual care in change of CRP
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in CRP | Baseline | 1.2 mg/L |
| PAP-therapy (CPAP or ASV) | Change in CRP | Follow up 6 months | 1.0 mg/L |
| Control Group | Change in CRP | Baseline | 1.0 mg/L |
| Control Group | Change in CRP | Follow up 6 months | 1.1 mg/L |
p-value: 0.6595% CI: [-1, 1.6]Regression, Linear
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
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in Left Ventricular Ejection Fraction | Baseline | 58.5 percentage | Standard Deviation 5.2 |
| PAP-therapy (CPAP or ASV) | Change in Left Ventricular Ejection Fraction | Follw up 6 months | 59.4 percentage | Standard Deviation 4.2 |
| Control Group | Change in Left Ventricular Ejection Fraction | Baseline | 57.9 percentage | Standard Deviation 5.2 |
| Control Group | Change in Left Ventricular Ejection Fraction | Follw up 6 months | 56.6 percentage | Standard Deviation 5.2 |
p-value: 0.00695% CI: [0.8, 4.5]Regression, Linear
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.
Time frame: Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Baseline Mental Component Summary score | 49.9 score on a scale | Standard Deviation 9.5 |
| PAP-therapy (CPAP or ASV) | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Follow up 6 months Mental Component Summary score | 52.5 score on a scale | Standard Deviation 8.7 |
| PAP-therapy (CPAP or ASV) | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Baseline Physical Component Summary score | 43.1 score on a scale | Standard Deviation 9.1 |
| PAP-therapy (CPAP or ASV) | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Follow up 6 months Physical Component Summary score | 43.6 score on a scale | Standard Deviation 10.2 |
| Control Group | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Follow up 6 months Physical Component Summary score | 45.9 score on a scale | Standard Deviation 9.6 |
| Control Group | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Baseline Mental Component Summary score | 52.8 score on a scale | Standard Deviation 6.6 |
| Control Group | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Baseline Physical Component Summary score | 43.3 score on a scale | Standard Deviation 10.2 |
| Control Group | Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) | Follow up 6 months Mental Component Summary score | 51.5 score on a scale | Standard Deviation 8.8 |
Comparison: Mental Component Summary scorep-value: 0.05895% CI: [-0.1, 5.8]Regression, Linear
Comparison: Physical Component Summary scorep-value: 0.1695% CI: [-5.1, 0.8]Regression, Linear
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)
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported
Population: Baseline and 6 months reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score | Baseline | 8.2 score on a scale | Standard Deviation 3.1 |
| PAP-therapy (CPAP or ASV) | Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score | Follow up 6 months | 7.1 score on a scale | Standard Deviation 3.6 |
| Control Group | Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score | Baseline | 7.5 score on a scale | Standard Deviation 3.3 |
| Control Group | Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score | Follow up 6 months | 7.5 score on a scale | Standard Deviation 3.7 |
p-value: 0.1195% CI: [-2, 0.2]Regression, Linear
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.
Time frame: 6 months, 12 months and 18 months
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.
Time frame: 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.
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | Baseline | 17.4 score on a scale | Standard Deviation 1.9 |
| PAP-therapy (CPAP or ASV) | Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | Follow up 6 months | 17.6 score on a scale | Standard Deviation 2 |
| Control Group | Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | Baseline | 17.7 score on a scale | Standard Deviation 2 |
| Control Group | Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) | Follow up 6 months | 17.7 score on a scale | Standard Deviation 2 |
p-value: 0.8595% CI: [-0.5, 0.6]Regression, Linear
Secondary
Change in the Cardiac Marker NT-proBNP.
Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.
Time frame: 6 months, 12 months. Baseline and 6 months reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PAP-therapy (CPAP or ASV) | Change in the Cardiac Marker NT-proBNP. | Baseline | 95.5 ng/L |
| PAP-therapy (CPAP or ASV) | Change in the Cardiac Marker NT-proBNP. | Follow up 6 months | 102.5 ng/L |
| Control Group | Change in the Cardiac Marker NT-proBNP. | Baseline | 84 ng/L |
| Control Group | Change in the Cardiac Marker NT-proBNP. | Follow up 6 months | 87 ng/L |
p-value: 0.38995% CI: [-103.4, 40.7]Regression, Linear
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.
Time frame: 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
Time frame: 6 months and 12 months
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
Time frame: 6 months and 12 months
Secondary
Lung Function Test as Assessed by Spirometry
Lung function test as assessed by spirometry
Time frame: Baseline, 6 months
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.
Time frame: Baseline to last three months of the intervention
Population: The proportion of patients with at least 25% reduction in AF burden
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PAP-therapy (CPAP or ASV) | Number of Participants With More Than 25% Reduction in AF Burden | 22 Participants |
| Control Group | Number of Participants With More Than 25% Reduction in AF Burden | 17 Participants |
p-value: 0.33Chi-squared