- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02727192
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oslo, Norway, 0424
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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).
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Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
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NO_INTERVENTION: Control group
No sleep apnea treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in AF Burden
Time Frame: Baseline to the last month of intervention period
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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.
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Baseline to the last month of intervention period
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Change in AF Burden
Time Frame: Comparing Baseline to the last five months of the intervention period
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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).
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Comparing Baseline to the last five months of the intervention period
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Number of Participants With More Than 25% Reduction in AF Burden
Time Frame: Baseline to last three months of the intervention
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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.
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Baseline to last three months of the intervention
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Change of Recurrence Rate After Ablation, as Measured by Loop Recorder
Time Frame: 12 months
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Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.
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12 months
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Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)
Time Frame: 6 months, 12 months and 18 months
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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).
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6 months, 12 months and 18 months
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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.
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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.
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Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.
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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
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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)
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6 months, 12 months and 18 months. Baseline and 6 months reported
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Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.
Time Frame: 6 months, 12 months and 18 months
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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.
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6 months, 12 months and 18 months
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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.
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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.
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6 months, 12 months and 18 months. Baseline and 6 months reported.
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Change in Symptoms of Sleep Apnea Measured by the STOP-Bang
Time Frame: 6 months, 12 months and 18 months
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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.
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6 months, 12 months and 18 months
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Change in CRP
Time Frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
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Difference between PAP treatment and usual care in change of CRP
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6 months, 12 months and 18 months. Baseline and 6 months reported.
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Change in Left Ventricular Ejection Fraction
Time Frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
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Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco
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6 months, 12 months and 18 months. Baseline and 6 months reported.
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Change in the Cardiac Marker NT-proBNP.
Time Frame: 6 months, 12 months. Baseline and 6 months reported.
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Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.
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6 months, 12 months. Baseline and 6 months reported.
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Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.
Time Frame: 6 months and 12 months
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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
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6 months and 12 months
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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
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Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording
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6 months and 12 months
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Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Time Frame: Baseline to follow up 6 months
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Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
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Baseline to follow up 6 months
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Lung Function Test as Assessed by Spirometry
Time Frame: Baseline, 6 months
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Lung function test as assessed by spirometry
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Baseline, 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lars Gullestad, MD PhD, Oslo University Hospital
Publications and helpful links
General Publications
- Traaen GM, Aakeroy L, Hunt TE, Overland B, Bendz C, Sande LO, Aakhus S, Fagerland MW, Steinshamn S, Anfinsen OG, Massey RJ, Broch K, Ueland T, Akre H, Loennechen JP, Gullestad L. Effect of Continuous Positive Airway Pressure on Arrhythmia in Atrial Fibrillation and Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.
- Traaen GM, Aakeroy L, Hunt TE, Overland B, Lyseggen E, Aukrust P, Ueland T, Helle-Valle T, Steinshamn S, Edvardsen T, Khiabani Zare H, Aakhus S, Akre H, Anfinsen OG, Loennechen JP, Gullestad L. Treatment of sleep apnea in patients with paroxysmal atrial fibrillation: design and rationale of a randomized controlled trial. Scand Cardiovasc J. 2018 Dec;52(6):372-377. doi: 10.1080/14017431.2019.1567933. Epub 2019 Feb 5.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Arrhythmias, Cardiac
- Sleep Apnea Syndromes
- Respiratory Aspiration
- Apnea
- Atrial Fibrillation
Other Study ID Numbers
- Gullestad
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