Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-13 @ 7:46 AM
Study NCT ID:
NCT00906958
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2009-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'alison.wimms@resmed.com', 'phone': '+44 7901332675', 'title': 'Alison Wimms', 'organization': 'ResMed Ltd'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 consecutive nights', 'eventGroups': [{'id': 'EG000', 'title': 'Nexus Flow Generator', 'description': 'Modified AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No Adverse Events were reported during the trial', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VPAP Flow Generator 25', 'description': 'Standard AutoSet for the treatment of OSA. Participants used this device while sleeping for one night. No adverse events were reported during the trial', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Apnoea-Hypopnoea Index (AHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexus Flow Generator', 'description': 'Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.'}, {'id': 'OG001', 'title': 'VPAP Flow Generator 25', 'description': 'Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.69', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \\& VPAP Auto 25', 'unitOfMeasure': 'Events/Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.'}, {'type': 'PRIMARY', 'title': 'Oxygen Desaturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexus Flow Generator', 'description': 'Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.'}, {'id': 'OG001', 'title': 'VPAP Flow Generator 25', 'description': 'Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '1.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'Number of oxygen desaturations per hour of sleep', 'unitOfMeasure': 'Events/Hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.'}, {'type': 'SECONDARY', 'title': 'Comfort of Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexus Flow Generator', 'description': 'Participants were randomised for Nexus Flow Generator group for one night.\n\nNexus Flow Generator: The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.'}, {'id': 'OG001', 'title': 'VPAP Flow Generator 25', 'description': 'Participants were randomised for VPAP Flow Generator 25 group for one night.\n\nVPAP Flow Generator 25: Exiting VPAP Auto 25 Flow Generator with A10 Algorithm'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': "Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale", 'unitOfMeasure': 'Scores on a Scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.'}, {'type': 'SECONDARY', 'title': 'Satisfaction of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexus Flow Generator', 'description': 'Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.'}, {'id': 'OG001', 'title': 'VPAP Flow Generator 25', 'description': 'Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': "Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.'}, {'type': 'SECONDARY', 'title': 'Refreshed Feel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexus Flow Generator', 'description': 'Participants were randomised to Nexus Flow Generator with modified auto set algorithm group for one night.'}, {'id': 'OG001', 'title': 'VPAP Flow Generator 25', 'description': 'Participants were randomised to VPAP Flow Generator Auto 25 with A10 algorithm group for one night.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '10'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in the study were those who were on CPAP therapy for no less than 6 months and were on auto adjustment mode.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Modified Autoset (Nexus Flow Generator)', 'description': 'AutoSet algorithms measure breathing patterns and respond to increase or decresase pressures to overcome obstructive sleep apnea. The modified AutoSet algorithm contains software updates to better measure and respond to sleep apnea. Participants used this device for one night, followed by the standard AutoSet, in a randomised order'}, {'id': 'FG001', 'title': 'VPAP Flow Generator 25', 'description': 'Existing AutoSet algorithm for the treatment of obstructive sleep apnea. Participants used this device for one night, followed by the modified AutoSet algorithm, in a randomised order'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This was a cross-over study, therefore all participants were assigned to both interventions, for one night each, in a randomised order'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2009-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2009-05-13', 'resultsFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-25', 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnoea-Hypopnoea Index (AHI)', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \\& VPAP Auto 25'}, {'measure': 'Oxygen Desaturation Index', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'Number of oxygen desaturations per hour of sleep'}], 'secondaryOutcomes': [{'measure': 'Comfort of Breathing', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': "Participant's Comfort Rating in one question: How comfortable/uncomfortable was the CPAP device to breathe on? Ratings from 0 (very uncomfortable) to 10 (very comfortable) on a Likert Scale"}, {'measure': 'Satisfaction of Treatment', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': "Participant's treatment satisfaction in one question: How much did the CPAP disturb your sleep last night? Rating from 0 (a lot) to 10 (not at all) on a Likert Scale"}, {'measure': 'Refreshed Feel', 'timeFrame': 'One Night On Each Arm, approximately 8 hours each night', 'description': 'Participants rated 0 (not refreshed at all) to 10 (very refreshed) on Likert Scale on one question: How refreshed did you feel this morning?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.', 'detailedDescription': 'Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-80 years\n* Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months\n* Patients who are using ResMed masks\n\nExclusion Criteria:\n\n* Patients who are unable to provide written informed consent\n* Patients who are unable to comprehend written and spoken English\n* Patients who are using Bilevel PAP\n* Patients who are pregnant\n* Patients who are suffering any of the following:\n\n * Acute respiratory infection\n * Acute sinusitis, otitis media or perforated eardrum\n * Pneumothorax or pneumomediastinum\n * Recent history of severe epistaxis requiring medical attention'}, 'identificationModule': {'nctId': 'NCT00906958', 'briefTitle': 'Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.', 'nctIdAliases': ['NCT00773396'], 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '08177-0608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nexus Flow Generator', 'description': 'Participants were randomised to Nexus Flow Generator group for one night.', 'interventionNames': ['Device: Nexus Flow Generator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VPAP Flow Generator 25', 'description': 'Participants were randomised to VPAP Flow Generator 25 group for one night.', 'interventionNames': ['Device: VPAP Flow Generator 25']}], 'interventions': [{'name': 'Nexus Flow Generator', 'type': 'DEVICE', 'description': 'The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilises an improved algorithm which should maintain or enhance the effectiveness of the treatment.', 'armGroupLabels': ['Nexus Flow Generator']}, {'name': 'VPAP Flow Generator 25', 'type': 'DEVICE', 'description': 'Exiting VPAP Auto 25 Flow Generator with A10 Algorithm', 'armGroupLabels': ['VPAP Flow Generator 25']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2135', 'city': 'Bella Vista', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Centre for Healthy Sleep', 'geoPoint': {'lat': -33.74127, 'lon': 150.95456}}], 'overallOfficials': [{'name': 'Klaus Schindhelm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ResMed/The University of New South Wales'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}