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Completed

NCT Number: NCT02727192

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

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.

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Key information

Conditions

Sleep Disordered Breathing Apnea Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Paroxysmal Atrial Fibrillation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAP (CPAP or ASV)

Device

Patients will be randomized to treatment of Sleep Apnea with a CPAP or control

Primary outcomes

  1. Change in AF Burden

    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.

    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 outcomes

  1. Change in AF Burden

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    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

  16. Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)

    Time frame: 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

    Time frame: Baseline, 6 months

    Lung function test as assessed by spirometry

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Medtronic
  • Norwegian Health Association
  • ResMed

Registry information

Official study title

Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 4, 2016
Registry last updated
Jun 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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