Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT00751335
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2008-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, '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': 'CPAP.trial@fphcare.co.nz', 'phone': '+64 09 574 0100', 'title': 'Clinical Research Scientist', 'phoneExt': '7044', 'organization': 'Fisher and Paykel Healthcare'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'All data for this trial has been lost. All case report forms and consent forms were lost and therefore, there are no results to report as no data exists.', 'eventGroups': [{'id': 'EG000', 'title': 'CPAP With ThermoSmart, Then CPAP Without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CPAP Without ThermoSmart, Then CPAP With ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CPAP Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP With ThermoSmart, Then CPAP Without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}, {'id': 'OG001', 'title': 'CPAP Without ThermoSmart, Then CPAP With ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}], 'timeFrame': '1, 4 & 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists'}, {'type': 'SECONDARY', 'title': 'Subjective & Objective Sleep Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CPAP With ThermoSmart, Then CPAP Without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}, {'id': 'OG001', 'title': 'CPAP Without ThermoSmart, Then CPAP With ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}], 'timeFrame': '1, 4 & 8 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'All data from this trial has been lost. This includes all case report forms and consent forms and therefore, there are no results to report as no data exists'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CPAP With ThermoSmart, Then CPAP Without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}, {'id': 'FG001', 'title': 'CPAP Without ThermoSmart, Then CPAP With ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All data from this trial has been lost This includes all case report forms and consent forms and therefore, there are no results to report as no data exists'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CPAP With ThermoSmart, Then CPAP Without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}, {'id': 'BG001', 'title': 'CPAP Without ThermoSmart, Then CPAP With ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'All data from this trial has been lost. This includes all case report forms and consent forms and therefore, there are no results to report as no data exists.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2008-09-10', 'resultsFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-03', 'studyFirstPostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPAP Compliance', 'timeFrame': '1, 4 & 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Subjective & Objective Sleep Parameters', 'timeFrame': '1, 4 & 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Humidification', 'Continuous Positive Airway Pressure'], 'conditions': ['Sleep Apnea, Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://fphcare.com', 'label': 'Fisher \\& Paykel Healthcare'}]}, 'descriptionModule': {'briefSummary': 'That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.\n3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity\n4. Patient willing to give informed consent and follow study protocol.\n\nExclusion Criteria:\n\n1. Wake resting SpO2 \\< 90%\n2. Patient requires BiLevel PAP or supplemental oxygen\n3. The patient is medically unstable (e.g. respiratory or cardiac failure)\n4. Patient unwilling to give informed consent or follow study protocol.'}, 'identificationModule': {'nctId': 'NCT00751335', 'briefTitle': 'ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure', 'orgStudyIdInfo': {'id': 'FPHC SLA 2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP with ThermoSmart, then CPAP without ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'interventionNames': ['Device: CPAP with ThermoSmart, then CPAP without ThermoSmart']}, {'type': 'EXPERIMENTAL', 'label': 'CPAP without ThermoSmart, then CPAP with ThermoSmart', 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'interventionNames': ['Device: CPAP without ThermoSmart, then CPAP with ThermoSmart']}], 'interventions': [{'name': 'CPAP with ThermoSmart, then CPAP without ThermoSmart', 'type': 'DEVICE', 'otherNames': ['ThermoSmart'], 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'armGroupLabels': ['CPAP with ThermoSmart, then CPAP without ThermoSmart']}, {'name': 'CPAP without ThermoSmart, then CPAP with ThermoSmart', 'type': 'DEVICE', 'otherNames': ['ThermoSmart'], 'description': 'CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.\n\nCPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.', 'armGroupLabels': ['CPAP without ThermoSmart, then CPAP with ThermoSmart']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60007', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Suburban Lung Associates', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Clifford A Massie, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Suburban Lung Asssociates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Suburban Lung Associates', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}