An interventional study of PAP (CPAP or ASV) in Sleep Disordered Breathing, Sleep Apnea and Paroxysmal Atrial Fibrillation, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 109 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
No sleep apnea treatment
Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
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.
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
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
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
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
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
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.
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
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
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.
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
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.
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.
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.
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
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
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
Lung Function Test as Assessed by Spirometry
Lung function test as assessed by spirometry
Time frame: Baseline, 6 months
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.
| Milestone | CPAP-therapy | Control Group | ASV-therapy |
|---|---|---|---|
| Started | 54 | 54 | 1 |
| Completed | 53 | 54 | 1 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
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.
| percentage of time in AF | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 5.6 ± 8.3 | 5.0 ± 8.9 |
| Last three months of intervention | 4.1 ± 6.5 | 4.3 ± 9.4 |
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.
| percentage of time in AF | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 5.6 ± 8.3 | 5.0 ± 8.9 |
| Last month of the intervention period | 4.6 ± 8.1 | 5.1 ± 10.8 |
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).
| percentage of time in AF | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 5.6 ± 8.3 | 5.0 ± 8.9 |
| 5 months intervention period | 4.5 ± 6.4 | 4.6 ± 9.8 |
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.
| Participants | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Number of Participants With More Than 25% Reduction in AF Burden | 22 | 17 |
Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
| score on a scale | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| 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 |
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)
| score on a scale | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 8.2 ± 3.1 | 7.5 ± 3.3 |
| Follow up 6 months | 7.1 ± 3.6 | 7.5 ± 3.7 |
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.
Results for this outcome have not been posted.
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.
| score on a scale | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 17.4 ± 1.9 | 17.7 ± 2.0 |
| Follow up 6 months | 17.6 ± 2.0 | 17.7 ± 2.0 |
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.
Results for this outcome have not been posted.
Difference between PAP treatment and usual care in change of CRP
| mg/L | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 1.2 (0.8 to 1.9) | 1.0 (0.8 to 2.6) |
| Follow up 6 months | 1.0 (0.7 to 2.1) | 1.1 (0.8 to 2.3) |
Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco
| percentage | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 58.5 ± 5.2 | 57.9 ± 5.2 |
| Follw up 6 months | 59.4 ± 4.2 | 56.6 ± 5.2 |
Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.
| ng/L | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 95.5 (50 to 152.3) | 84 (50 to 170.5) |
| Follow up 6 months | 102.5 (50.7 to 190.3) | 87 (50 to 229.5) |
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
Results for this outcome have not been posted.
Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording
Results for this outcome have not been posted.
Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
| Kg/m ̂ 2 | PAP-therapy (CPAP or ASV) | Control Group |
|---|---|---|
| Baseline | 29.8 ± 4.8 | 29.8 ± 4.1 |
| Follow up 6 months | 29.6 ± 5.1 | 29.6 ± 4.2 |
Lung function test as assessed by spirometry
Results for this outcome have not been posted.
Collected over 5 months (intervention period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CPAP-therapy | 0/53 (0%) | 6/53 (11.3%) | 0/53 (0%) |
| Control Group | 0/54 (0%) | 2/54 (3.7%) | 0/54 (0%) |
| ASV Therapy | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | CPAP-therapy | Control Group | ASV Therapy |
|---|---|---|---|
| Pacemaker implantation due to syncope and prolonged pausesCardiac disorders | 2/53 | 0/54 | 0/1 |
| Hospitalization due to symptomatic atrial fibrillationCardiac disorders | 2/53 | 1/54 | 0/1 |
| Hospitalization due to syncopeCardiac disorders | 1/53 | 0/54 | 0/1 |
| Hospitalization due to chest painCardiac disorders | 1/53 | 0/54 | 0/1 |
| Hospitalization due to hemorrhagic strokeVascular disorders | 0/53 | 1/54 | 0/1 |
| Age, Continuous(years) | PAP-therapy (CPAP or ASV) | Control Group | Total |
|---|---|---|---|
| Mean | 63.0 ± 7.4 | 62.1 ± 7.8 | 62.6 ± 7.5 |
| Sex: Female, Male(Participants) | PAP-therapy (CPAP or ASV) | Control Group | Total |
|---|---|---|---|
| Female | 15 | 11 | 26 |
| Male | 39 | 43 | 82 |
| Race (NIH/OMB)(Participants) | PAP-therapy (CPAP or ASV) | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 54 | 54 | 108 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | PAP-therapy (CPAP or ASV) | Control Group | Total |
|---|---|---|---|
| Norway | 54 | 54 | 108 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oslo University Hospital