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

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02727192
• Collaborator: Norwegian Health Association (Other), Medtronic (Industry), ResMed (Industry)
• Enrollment: 109
• Location: 1
• Arms: 2
• Actual Duration (Months): 55.4
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disordered Breathing; Sleep Apnea; Paroxysmal Atrial Fibrillation	Device: PAP (CPAP or ASV)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation
• Actual Study Start Date: Jan 21, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PAP-therapy (CPAP or ASV) Patients are randomized to either intervention Group: Positive airway pressure therapy (PAP-therapy) or Control. Patients in the intervention arm will be treated with PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	Device: PAP (CPAP or ASV); Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
No Intervention: Control group No sleep apnea treatment

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Change in AF Burden [Comparing Baseline to the last five 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 five months of the intervention period (the whole intervention period).

3. 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.

4. 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.

5. 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).

6. 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.

7. 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)

8. 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.

9. 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.

10. 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.

11. 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

12. 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

13. 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.

14. 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

15. 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

16. 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)

17. Lung Function Test as Assessed by Spirometry [Baseline, 6 months]

    Lung function test as assessed by spirometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

• Oslo University Hospital
• Norwegian Health Association
• Medtronic
• ResMed

Investigators

• Principal Investigator: Lars Gullestad, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

• Study Protocol - Nov 7, 2016
• Statistical Analysis Plan - Nov 29, 2019

More Information

Publications

None provided.

• Responsible Party: Lars Gullestad, Professor MD, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02727192
• Other Study ID Numbers: Gullestad
• First Posted: Apr 4, 2016
• Last Update Posted: Jun 22, 2021
• Last Verified: May 1, 2021

• Keywords provided by Lars Gullestad, Professor MD, Oslo University Hospital: Atrial fibrillation; CPAP; Sleep apnea; Sleep disordered breathing
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Atrial Fibrillation

Study Results

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 Detail

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.

Arm/Group Title	CPAP-therapy	Control Group	ASV-therapy
Arm/Group Description	CPAP-therapy (Continous Positive Airway Pressure)	No sleep apnea treatment (usual care)	ASV-therapy (Adaptive Servo-Ventilation)
Period Title: Overall Study
STARTED	54	54	1
COMPLETED	53	54	1
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group	Total
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)	Total of all reporting groups
Overall Participants	54	54	108
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.0 (7.4)	62.1 (7.8)	62.6 (7.5)
Sex: Female, Male (Count of Participants)
Female	15 27.8%	11 20.4%	26 24.1%
Male	39 72.2%	43 79.6%	82 75.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	54 100%	54 100%	108 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Norway	54 100%	54 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Change in AF Burden
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	5.6 (8.3)	5.0 (8.9)
Last three months of intervention	4.1 (6.5)	4.3 (9.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.520
	Comments	A two-sided significance level of 5% was considered to indicate statistical significance.
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -2.6 to 1.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in AF Burden
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	5.6 (8.3)	5.0 (8.9)
Last month of the intervention period	4.6 (8.1)	5.1 (10.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.440
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -3.3 to 1.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in AF Burden
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	5.6 (8.3)	5.0 (8.9)
5 months intervention period	4.5 (6.4)	4.6 (9.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.410
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -2.1 to 0.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Number of Participants With More Than 25% Reduction in AF Burden
Description	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

Outcome Measure Data

Analysis Population Description

The proportion of patients with at least 25% reduction in AF burden

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Count of Participants [Participants]	22 40.7%	17 31.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.33
	Comments
	Method	Chi-squared
	Comments
Method of Estimation	Estimation Parameter	Difference in Percentage of Participants
	Estimated Value	-9.3
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change of Recurrence Rate After Ablation, as Measured by Loop Recorder
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline Mental Component Summary score	49.9 (9.5)	52.8 (6.6)
Follow up 6 months Mental Component Summary score	52.5 (8.7)	51.5 (8.8)
Baseline Physical Component Summary score	43.1 (9.1)	43.3 (10.2)
Follow up 6 months Physical Component Summary score	43.6 (10.2)	45.9 (9.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments	Mental Component Summary score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; -0.1 to 5.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments	Physical Component Summary score
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.160
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.1
	Confidence Interval	(2-Sided) 95%; -5.1 to 0.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score
Description	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

Outcome Measure Data

Analysis Population Description

Baseline and 6 months reported

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	8.2 (3.1)	7.5 (3.3)
Follow up 6 months	7.1 (3.6)	7.5 (3.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.110
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -2.0 to 0.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	17.4 (1.9)	17.7 (2.0)
Follow up 6 months	17.6 (2.0)	17.7 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.850
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.5 to 0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change in Symptoms of Sleep Apnea Measured by the STOP-Bang
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Change in CRP
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	1.2	1.0
Follow up 6 months	1.0	1.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.650
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0.3
	Confidence Interval	(2-Sided) 95%; -1.0 to 1.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change in Left Ventricular Ejection Fraction
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	58.5 (5.2)	57.9 (5.2)
Follw up 6 months	59.4 (4.2)	56.6 (5.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 0.8 to 4.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change in the Cardiac Marker NT-proBNP.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	95.5	84
Follow up 6 months	102.5	87

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.389
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-31.4
	Confidence Interval	(2-Sided) 95%; -103.4 to 40.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Description	Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Time Frame	Baseline to follow up 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PAP-therapy (CPAP or ASV)	Control Group
Arm/Group Description	PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).	No sleep apnea treatment (usual care)
Measure Participants	54	54
Baseline	29.8 (4.8)	29.8 (4.1)
Follow up 6 months	29.6 (5.1)	29.6 (4.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PAP-therapy (CPAP or ASV), Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.697
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.3 to 0.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Lung Function Test as Assessed by Spirometry
Description	Lung function test as assessed by spirometry
Time Frame	Baseline, 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	5 months (intervention period)
Adverse Event Reporting Description	Adverse event collection was obtained by regular investigator assessment, and data collection from the loop recorder (prolonged pauses).
Arm/Group Title	CPAP-therapy		Control Group		ASV Therapy
Arm/Group Description	Positive airway pressure therapy (CPAP)		No sleep apnea treatment		Adaptive Servo Ventilation (ASV)
All Cause Mortality
	CPAP-therapy		Control Group		ASV Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/54 (0%)		0/1 (0%)
Serious Adverse Events
	CPAP-therapy		Control Group		ASV Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/53 (11.3%)		2/54 (3.7%)		0/1 (0%)
Cardiac disorders
Pacemaker implantation due to syncope and prolonged pauses	2/53 (3.8%)	2	0/54 (0%)	0	0/1 (0%)	0
Hospitalization due to syncope	1/53 (1.9%)	1	0/54 (0%)	0	0/1 (0%)	0
Hospitalization due to symptomatic atrial fibrillation	2/53 (3.8%)	3	1/54 (1.9%)	1	0/1 (0%)	0
Hospitalization due to chest pain	1/53 (1.9%)	1	0/54 (0%)	0	0/1 (0%)	0
Vascular disorders
Hospitalization due to hemorrhagic stroke	0/53 (0%)	0	1/54 (1.9%)	1	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	CPAP-therapy		Control Group		ASV Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/54 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.