Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT00823134
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of ApneaLink Plus Scoring Capabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'oliver.munt@resmed.de', 'phone': '0899901', 'title': 'Oliver Munt', 'phoneExt': '00', 'organization': 'ResMed Germany Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PSG/ApneaLink', 'description': 'Sleep Evaluation under Polysomnography and with ApneaLink', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PSG/ApneaLink', 'description': 'Sleep Evaluation under Polysomnography and with ApneaLink'}], 'classes': [{'title': 'AHI_psg', 'categories': [{'measurements': [{'value': '14.77', 'spread': '14.97', 'groupId': 'OG000'}]}]}, {'title': 'AHI_al', 'categories': [{'measurements': [{'value': '12.14', 'spread': '12.04', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '4.7', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'one night', 'description': 'Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts', 'unitOfMeasure': 'events/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.968', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Correlation coefficient (Bland-Altman)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.75', 'groupDescription': 'Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of \\>75% will be seen as threshold for validity.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).'}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.935', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.852', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.939', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.754', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}, {'type': 'PRIMARY', 'title': 'Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AL + Polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).\n\nApneaLink Plus: Device used to evaluate for the presence of obstructive, central or mixed apneas'}], 'classes': [{'categories': [{'measurements': [{'value': '0.905', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 night', 'description': 'The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.', 'unitOfMeasure': 'Correlation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant undergoes one night of sleep while wearing an Apnea Link device and polysomnography is being recorded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PSG/ApneaLink', 'description': 'Sleep Evaluation under Polysomnography and with ApneaLink'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Invalid measurement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PSG/ApneaLink', 'description': 'Sleep Evaluation under Polysomnography and with ApneaLink'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.73', 'spread': '16.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.77', 'spread': '4.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-29', 'studyFirstSubmitDate': '2009-01-13', 'resultsFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2009-01-14', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-29', 'studyFirstPostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the Apnoea-Hypopnea-Index (Number of Apneas (All Apneas, Obstructive, Mixed, Central) and Number of Hypopneas) Between ApneaLink Plus and a PSG System Within the Same Evaluation Period', 'timeFrame': 'one night', 'description': 'Apnoea is defined as a decrease in flow of ≥90% from baseline for at least 10 seconds; hypopnea is a decrease in flow ≥30% from baseline for at least 10 seconds and an oxygen desaturation of ≥4%; obstructive: breathing efforts are ongoing; central: no breathing efforts'}, {'measure': 'Correlation Coefficient of Apnoea-Hypopnea-Index (AHI) (PSG) - AHI (AL)', 'timeFrame': '1 night', 'description': 'The AHI (PSG) values and AHI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}, {'measure': 'Correlation Coefficient of Apnoea-Index (AI) (PSG) - AI (AL)', 'timeFrame': '1 night', 'description': 'The AI (PSG) values and AI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}, {'measure': 'Correlation Coefficient of Obstructive-Apnoea-Index (OAI) (PSG) - OAI (AL)', 'timeFrame': '1 night', 'description': 'The OAI (PSG) values and OAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}, {'measure': 'Correlation Coefficient of Central-Apnoea-Index (CAI) (PSG) - CAI (AL)', 'timeFrame': '1 night', 'description': 'The CAI (PSG) values and CAI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}, {'measure': 'Correlation Coefficient of Apnoea-Index (HI) (PSG) - HI (AL)', 'timeFrame': '1 night', 'description': 'The HI (PSG) values and HI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}, {'measure': 'Correlation Coefficient of Obstructive-Apnoea-Index (ODI) (PSG) - ODI (AL)', 'timeFrame': '1 night', 'description': 'The ODI (PSG) values and ODI ApneaLink Plus (AL) value will be collected in one graph (Bland-Altmann Plot) and the correlation coefficient will be calculated. A correlation of \\>75% will be seen as threshold for validity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Apnea, Central', 'Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the following topics:\n\n* Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.\n* Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.\n* Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet', 'detailedDescription': '* Determine the accuracy of ApneaLink Plus in separating Apneas into Obstructive Apneas, Mixed Apneas and Central Apneas.\n* Determine the accuracy of ApneaLink Plus in scoring Hypopneas according to the 2008 guidelines of the AASM = American Academy of Sleep Medcine.\n* Determine whether patients can start and stop the recorder and are able to attach the additional effort sensor by themselves using the patient instruction sheet'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to give written informed consent\n* Adult patients who are 18 years of age or older\n* No alcohol consumption 12 hrs before and during the trial period\n* Normally sleep more than 3 hours per night\n\nExclusion Criteria:\n\n* Unable to comprehend written and spoken German.\n* Pregnant\n* Patients who use of Bilevel PAP or CPAP therapy during the PSG\n* Unsuitable for inclusion in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT00823134', 'briefTitle': 'Evaluation of ApneaLink Plus Scoring Capabilities', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Evaluation of ApneaLink Plus Scoring Capabilities', 'orgStudyIdInfo': {'id': 'D2231-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AL + polysomnography', 'description': 'Participant wears an Apnea Link sleep apnoea screening device during the polysomnography to detect apnoeas (obstructive, central).', 'interventionNames': ['Device: ApneaLink Plus']}], 'interventions': [{'name': 'ApneaLink Plus', 'type': 'DEVICE', 'otherNames': ['AL Plus'], 'description': 'Device used to evaluate for the presence of obstructive, central or mixed apneas', 'armGroupLabels': ['AL + polysomnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88239', 'city': 'Wangen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen', 'geoPoint': {'lat': 47.6895, 'lon': 9.83247}}], 'overallOfficials': [{'name': 'Knut Joechle, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ResMed'}, {'name': 'Heribert Knape, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik für Atemwegserkrankungen und Allergien, Fachkliniken Wangen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}