Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:16 AM
Study NCT ID:
NCT02727192
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lars.gullestad@medisin.uio.no', 'phone': '+4797644772', 'title': 'Professor Lars Gullestad', 'organization': 'Oslo University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 months (intervention period)', 'description': 'Adverse event collection was obtained by regular investigator assessment, and data collection from the loop recorder (prolonged pauses).', 'eventGroups': [{'id': 'EG000', 'title': 'CPAP-therapy', 'description': 'Positive airway pressure therapy (CPAP)', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'ASV Therapy', 'description': 'Adaptive Servo Ventilation (ASV)', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pacemaker implantation due to syncope and prolonged pauses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to symptomatic atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to hemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in AF Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Last three months of intervention', 'categories': [{'measurements': [{'value': '4.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.520', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '1.3', 'pValueComment': 'A two-sided significance level of 5% was considered to indicate statistical significance.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.', '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.', 'unitOfMeasure': 'percentage of time in AF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in AF Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Last month of the intervention period', 'categories': [{'measurements': [{'value': '4.6', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.440', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to the last month of intervention period', '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.', 'unitOfMeasure': 'percentage of time in AF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in AF Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': '5 months intervention period', 'categories': [{'measurements': [{'value': '4.5', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.9', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Comparing Baseline to the last five months of the intervention period', '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).', 'unitOfMeasure': 'percentage of time in AF', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With More Than 25% Reduction in AF Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-9.3', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to last three months of the intervention', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The proportion of patients with at least 25% reduction in AF burden'}, {'type': 'SECONDARY', 'title': 'Change of Recurrence Rate After Ablation, as Measured by Loop Recorder', 'timeFrame': '12 months', 'description': 'Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2021-12'}, {'type': 'SECONDARY', 'title': 'Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)', 'timeFrame': '6 months, 12 months and 18 months', '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).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline Mental Component Summary score', 'categories': [{'measurements': [{'value': '49.9', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 6 months Mental Component Summary score', 'categories': [{'measurements': [{'value': '52.5', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Physical Component Summary score', 'categories': [{'measurements': [{'value': '43.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 6 months Physical Component Summary score', 'categories': [{'measurements': [{'value': '43.6', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '45.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '5.8', 'groupDescription': 'Mental Component Summary score', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '0.8', 'groupDescription': 'Physical Component Summary score', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 6 months', 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported', '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)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline and 6 months reported'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.', 'timeFrame': '6 months, 12 months and 18 months', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-12'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 6 months', 'categories': [{'measurements': [{'value': '17.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.850', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.6', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Symptoms of Sleep Apnea Measured by the STOP-Bang', 'timeFrame': '6 months, 12 months and 18 months', '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in CRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.9'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '2.6'}]}]}, {'title': 'Follow up 6 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '2.1'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '2.3'}]}]}], 'analyses': [{'pValue': '0.650', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of CRP', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.5', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '57.9', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Follw up 6 months', 'categories': [{'measurements': [{'value': '59.4', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '0.8', 'ciUpperLimit': '4.5', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Cardiac Marker NT-proBNP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '152.3'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '170.5'}]}]}, {'title': 'Follow up 6 months', 'categories': [{'measurements': [{'value': '102.5', 'groupId': 'OG000', 'lowerLimit': '50.7', 'upperLimit': '190.3'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '229.5'}]}]}], 'analyses': [{'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.4', 'ciLowerLimit': '-103.4', 'ciUpperLimit': '40.7', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months, 12 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.', 'timeFrame': '6 months and 12 months', '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', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording', 'timeFrame': '6 months and 12 months', 'description': 'Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Follow up 6 months', 'categories': [{'measurements': [{'value': '29.6', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.697', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to follow up 6 months', 'description': 'Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)', 'unitOfMeasure': 'Kg/m ̂ 2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Lung Function Test as Assessed by Spirometry', 'timeFrame': 'Baseline, 6 months', 'description': 'Lung function test as assessed by spirometry', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2022-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPAP-therapy', 'description': 'CPAP-therapy (Continous Positive Airway Pressure)'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}, {'id': 'FG002', 'title': 'ASV-therapy', 'description': 'ASV-therapy (Adaptive Servo-Ventilation)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.\n\n21 patients without sleep apnea or mild sleep apnea (AHI\\<15) were included as a reference group.\n\nTherefore, 130 patients were included in the study, but only 109 were included for randomization.', 'preAssignmentDetails': '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.\n\nAll 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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PAP-therapy (CPAP or ASV)', 'description': 'PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No sleep apnea treatment (usual care)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Norway', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-07', 'size': 400171, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-04T07:31', 'hasProtocol': True}, {'date': '2019-11-29', 'size': 808612, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-02T11:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-27', 'studyFirstSubmitDate': '2016-03-29', 'resultsFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-27', 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in AF Burden', 'timeFrame': 'Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.', '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.'}], 'secondaryOutcomes': [{'measure': 'Change in AF Burden', 'timeFrame': 'Baseline to the last month of intervention period', '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.'}, {'measure': 'Change in AF Burden', 'timeFrame': 'Comparing Baseline to the last five months of the intervention period', '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).'}, {'measure': 'Number of Participants With More Than 25% Reduction in AF Burden', 'timeFrame': 'Baseline to last three months of the intervention', '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.'}, {'measure': 'Change of Recurrence Rate After Ablation, as Measured by Loop Recorder', 'timeFrame': '12 months', 'description': 'Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.'}, {'measure': 'Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)', 'timeFrame': '6 months, 12 months and 18 months', '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).'}, {'measure': 'Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)', 'timeFrame': 'Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.', '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.'}, {'measure': 'Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported', '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)'}, {'measure': 'Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.', 'timeFrame': '6 months, 12 months and 18 months', '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.'}, {'measure': 'Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', '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.'}, {'measure': 'Change in Symptoms of Sleep Apnea Measured by the STOP-Bang', 'timeFrame': '6 months, 12 months and 18 months', '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.'}, {'measure': 'Change in CRP', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of CRP'}, {'measure': 'Change in Left Ventricular Ejection Fraction', 'timeFrame': '6 months, 12 months and 18 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco'}, {'measure': 'Change in the Cardiac Marker NT-proBNP.', 'timeFrame': '6 months, 12 months. Baseline and 6 months reported.', 'description': 'Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.'}, {'measure': 'Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.', 'timeFrame': '6 months and 12 months', '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'}, {'measure': 'Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording', 'timeFrame': '6 months and 12 months', 'description': 'Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording'}, {'measure': 'Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)', 'timeFrame': 'Baseline to follow up 6 months', 'description': 'Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)'}, {'measure': 'Lung Function Test as Assessed by Spirometry', 'timeFrame': 'Baseline, 6 months', 'description': 'Lung function test as assessed by spirometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial fibrillation', 'CPAP', 'Sleep apnea', 'Sleep disordered breathing'], 'conditions': ['Sleep Disordered Breathing', 'Sleep Apnea', 'Paroxysmal Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '33938787', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30638392', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Male or female\n* Patients with paroxysmal AF scheduled for first or second catheter ablation\n* Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Unstable patients\n* Patients with left ventricular ejection fraction (LV-EF) \\< 45%\n* Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study\n* Bypass surgery within 6 months prior to the study\n* Patients with TIA or stroke within the previous 3 months\n* BMI \\> 40kg/m2\n* Drowsy drivers and/or sleepy patients with ESS (Epworth Sleepiness Score) \\> 15\n* Patients with interstitial lung diseases, severe obstructive lung defects, and thoracic myopathies or severe obstructive lung defects with FEV1 \\< 50% of predicted\n* Oxygen saturation \\< 90% at rest during the day\n* Poor compliance\n* Patients with single chamber pacemaker (or ICD)\n* Current use of PAP therapy\n* Patients using amiodarone'}, 'identificationModule': {'nctId': 'NCT02727192', 'briefTitle': 'Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'Gullestad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PAP-therapy (CPAP or ASV)', 'description': '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).', 'interventionNames': ['Device: PAP (CPAP or ASV)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No sleep apnea treatment'}], 'interventions': [{'name': 'PAP (CPAP or ASV)', 'type': 'DEVICE', 'description': 'Patients will be randomized to treatment of Sleep Apnea with a CPAP or control', 'armGroupLabels': ['PAP-therapy (CPAP or ASV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lars Gullestad, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Health Association', 'class': 'OTHER'}, {'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'ResMed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor MD', 'investigatorFullName': 'Lars Gullestad', 'investigatorAffiliation': 'Oslo University Hospital'}}}}