Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-21 @ 11:15 PM
Study NCT ID:
NCT02743520
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2016-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.ramos1@med.miami.edu', 'phone': '305-243-8393', 'title': 'Alberto Ramos, MD, MSPH, FAASM', 'organization': 'University of Miami, Miller School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Two weeks', 'description': 'Only intervention related adverse events were collected for the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2', 'description': 'New cases of atrial fibrillation as evaluated by the LifestarAct III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Frequent Ventricular Premature Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 2', 'description': 'More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Longest Duration of Atrial Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'timeFrame': 'Week 2', 'description': 'Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to software error, data could not be extracted for analysis for this outcome for all participants'}, {'type': 'SECONDARY', 'title': 'Atrial Fibrillation Episodes Lasting More Than Six Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'timeFrame': 'Week 2', 'description': 'In participants with atrial fibrillation as evaluated by the LifestarAct III.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to software error, data could not be extracted for analysis for this outcome for all participants'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Frequent Premature Atrial Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2', 'description': 'More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Event Monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.\n\nThe Lifestar Act III: The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-21', 'size': 233402, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-06T16:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2016-04-14', 'resultsFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-30', 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Definite Atrial Fibrillation (Defined as an Irregularly Irregular Rhythm With Absence of p Waves)', 'timeFrame': 'Week 2', 'description': 'New cases of atrial fibrillation as evaluated by the LifestarAct III.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Frequent Ventricular Premature Contractions', 'timeFrame': 'week 2', 'description': 'More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.'}, {'measure': 'Longest Duration of Atrial Fibrillation', 'timeFrame': 'Week 2', 'description': 'Longest duration of Atrial Fibrillation in minutes compare to the rests of Atrial Fibrillation in a 24 hours, as evaluated by the LifestarAct III.'}, {'measure': 'Atrial Fibrillation Episodes Lasting More Than Six Minutes', 'timeFrame': 'Week 2', 'description': 'In participants with atrial fibrillation as evaluated by the LifestarAct III.'}, {'measure': 'The Number of Participants With Frequent Premature Atrial Contractions', 'timeFrame': 'Week 2', 'description': 'More than 100 contraction during a 24 hour period as evaluated by the LifestarAct III.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['sleep apnea', 'arrhythmia detection'], 'conditions': ['Atrial Fibrillation', 'Arrhythmia', 'Stroke, Cardiovascular']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn about arrhythmia detection in obstructive sleep apnea (OSA). For several years patients with OSA have an increased likelihood of having irregular heartbeats. This study will determine how often patients with OSA have irregular heartbeats. This study will also define which OSA patients are most likely to have irregular heartbeats.\n\nThe participant is being asked to be in the study because the participant has been diagnosed with obstructive sleep apnea (OSA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of OSA within the last 12 months\n2. No previous diagnosis of atrial fibrillation\n3. Able and willing to follow-up as an outpatient\n4. Age 40-85 years\n\nExclusion Criteria:\n\n1. Life expectancy \\< 2 years\n2. Dementia or other neurologic condition which would make outpatient follow-up difficult\n3. CHADS score \\<2\n4. Alcohol or drug abuse which would interfere with outpatient follow-up\n5. Severe Congestive heart failure (NYHA class 3 or 4) or use of left ventricular assist device.\n6. Current dialysis treatment or planned treatment within 12 months\n7. Known bleeding disorder or prothrombin time \\>15 seconds\n8. Mechanical heart valve requiring anticoagulation\n9. Moderate to severe mitral stenosis or regurgitation\n10. Prior clinical diagnosis of ischemic stroke (radiologic infarcts are not excluded)\n11. Chronic obstructive pulmonary disease with oxygen dependence\n12. Pregnant patients or patients that plan to become pregnant within the course of the study\\*.\n13. Patients with anticipated need for a pacemaker during the course of the study \\*If any patients become pregnant during the course of the study, pregnancy outcomes will not be followed'}, 'identificationModule': {'nctId': 'NCT02743520', 'acronym': 'ADIOS', 'briefTitle': 'Arrhythmia Detection In Obstructive Sleep Apnea (ADIOS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Early Identification of Patients With Coexisting Atrial Fibrillation and Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '20150860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac event monitor', 'description': 'Participants will under go evaluation with a two week cardiac event monitor.', 'interventionNames': ['Device: The Lifestar Act III']}], 'interventions': [{'name': 'The Lifestar Act III', 'type': 'DEVICE', 'description': 'The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.', 'armGroupLabels': ['Cardiac event monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Alberto R Ramos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alberto Rafael Ramos', 'investigatorAffiliation': 'University of Miami'}}}}