Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-30 @ 1:00 PM
Study NCT ID:
NCT03470493
Status:
COMPLETED
Last Update Posted:
2021-05-20
First Post:
2018-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adam.benjafield@resmed.com', 'phone': '+61 466 634 609', 'title': 'Adam Benjafield', 'organization': 'ResMed'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'classes': [{'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '82.8', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines.\n\nThe REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.', 'unitOfMeasure': 'percent of agreement between AL and PSG', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with a respiratory event index (REI) ≥ 5 events per hour according to AL were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'classes': [{'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Total number of Obstructive events reported by the ApneaLink (AL) compared with total number of Obstructive Events reported by polysomnography (PSG). The Obstructive events of the AL are divided by the Obstructive events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825', 'unitOfMeasure': 'Weighted Kappa statistic', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with a respiratory event index (REI) ≥ 5 events per hour according to Apnealink were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Total number of Central events reported by the ApneaLink (AL) compared with total number of Central Events reported by polysomnography (PSG). The Central events of the AL are divided by the Central events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825', 'unitOfMeasure': 'Weighted Kappa statistic', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those with an REI over to equal to 5 were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Positive Likelihood Ratio of Apnealink Air', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) was calculated along with the associated one-sided 97.5% confidence interval. The positive likelihood ratio was compared with the threshold of 5 (AASM criteria for out-of-center testing devices12) using a Wald test.', 'unitOfMeasure': 'Likelihood Ratio', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with an REI above or equal to 5 were included in this analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'Met Primary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants', 'description': 'ApneaLink Air\n\nApneaLink Air: ApneaLink Air to be used on each participant undergoing PSG'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current PAP therapy user', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current oxygen user', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline population included participants that were considered eligible for the primary endpoint analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-31', 'size': 376666, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-03-23T16:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2018-02-28', 'resultsFirstSubmitDate': '2021-03-23', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-28', 'studyFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG)', 'timeFrame': 'Day 1', 'description': 'The Respiratory Event Index (REI) provided by the AL will be compared with the REI provided by the PSG test. REI will be scored according to American Academy of Sleep Medicine (AASM) 2012 guidelines.\n\nThe REI provided by the AL for each participant is divided by the REI provided by the PSG for the same participant to get the diagnostic sensitivity of the Apnealink.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic Sensitivity of Apnealink (AL) Compared With Polysomnography (PSG) to Identify Obstructive Events', 'timeFrame': 'Day 1', 'description': 'Total number of Obstructive events reported by the ApneaLink (AL) compared with total number of Obstructive Events reported by polysomnography (PSG). The Obstructive events of the AL are divided by the Obstructive events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825'}, {'measure': 'Diagnostic Sensitivity of the AL to Determine Central Events Compared With PSG', 'timeFrame': 'Day 1', 'description': 'Total number of Central events reported by the ApneaLink (AL) compared with total number of Central Events reported by polysomnography (PSG). The Central events of the AL are divided by the Central events of the PSG to get the diagnostic sensitivity. This is then compared with the threshold of 0.825'}, {'measure': 'Positive Likelihood Ratio of Apnealink Air', 'timeFrame': 'Day 1', 'description': 'The positive likelihood ratio (the estimated sensitivity divided by 1 minus the estimated specificity) was calculated along with the associated one-sided 97.5% confidence interval. The positive likelihood ratio was compared with the threshold of 5 (AASM criteria for out-of-center testing devices12) using a Wald test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep-disordered Breathing']}, 'descriptionModule': {'briefSummary': 'This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.', 'detailedDescription': 'The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.\n\nThe ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is 18 years of age or older\n* Participant is willing to provide informed consent\n* Participant is willing to participate in all study related procedures\n\nExclusion Criteria:\n\n* Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)\n* Requires use of oxygen therapy during sleep\n* Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)\n* Pregnant\n* Participant is unsuitable to participate in the study in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT03470493', 'briefTitle': 'ApneaLink Air Home Sleep Testing (HST) Device Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography', 'orgStudyIdInfo': {'id': 'SLP-17-10-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants', 'description': 'ApneaLink Air', 'interventionNames': ['Diagnostic Test: ApneaLink Air']}], 'interventions': [{'name': 'ApneaLink Air', 'type': 'DIAGNOSTIC_TEST', 'description': 'ApneaLink Air to be used on each participant undergoing PSG', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Richard Berry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}