N/A
N=109
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Sleep Disordered Breathing · Sleep Apnea · Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02727192 ↗Enrolled (actual)
109
Serious AEs
7.4%
Results posted
Jun 2021
Primary outcome: Primary: Change in AF Burden — 5.6; 5.0; 4.1; 4.3 percentage of time in AF — p=0.520
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PAP (CPAP or ASV) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oslo University Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in AF Burden |
5.6; 5.0; 4.5; 4.6 | 0.410 |
| SECONDARY Change in AF Burden |
5.6; 5.0; 4.5; 4.6 | 0.410 |
| SECONDARY Change in AF Burden |
5.6; 5.0; 4.5; 4.6 | 0.410 |
| SECONDARY Number of Participants With More Than 25% Reduction in AF Burden |
22; 17 | 0.33 |
| SECONDARY Change of Recurrence Rate After Ablation, as Measured by Loop Recorder |
— | — |
| SECONDARY Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS) |
— | — |
| SECONDARY Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) |
49.9; 52.8; 52.5; 51.5; 43.1; 43.3 | 0.058 |
| SECONDARY Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score |
8.2; 7.5; 7.1; 7.5 | 0.110 |
| SECONDARY Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire. |
— | — |
| SECONDARY Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ) |
17.4; 17.7; 17.6; 17.7 | 0.850 |
| SECONDARY Change in Symptoms of Sleep Apnea Measured by the STOP-Bang |
— | — |
| SECONDARY Change in CRP |
1.2; 1.0; 1.0; 1.1 | 0.650 |
| SECONDARY Change in Left Ventricular Ejection Fraction |
58.5; 57.9; 59.4; 56.6 | 0.006 sig |
| SECONDARY Change in the Cardiac Marker NT-proBNP. |
95.5; 84; 102.5; 87 | 0.389 |
| SECONDARY Examine the Effect of SA Treatment on Gene Expression of White Blood Cells. |
— | — |
| SECONDARY Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording |
— | — |
| SECONDARY Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita) |
29.8; 29.8; 29.6; 29.6 | 0.697 |
| SECONDARY Lung Function Test as Assessed by Spirometry |
— | — |
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.
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT02727192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.