Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-08 @ 7:55 AM
Study NCT ID:
NCT02535234
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2015-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Continuous Positive Airway Pressure Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.', 'timeFrame': '1 year', 'description': 'Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and comfort. The participants will answer the questions using an 11-point Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnoea']}, 'referencesModule': {'references': [{'pmid': '23589584', 'type': 'RESULT', 'citation': 'Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.'}, {'pmid': '8464434', 'type': 'RESULT', 'citation': 'Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.'}, {'pmid': '11991871', 'type': 'RESULT', 'citation': 'Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.'}]}, 'descriptionModule': {'briefSummary': 'Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Participant is willing to provide written informed consent\n* Participant is able to read and comprehend written and spoken English\n* Participant is ≥ 18 years of age\n* Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)\n* Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months\n* Participants is currently using the same mask type/variant as the interventional mask system to be evaluated\n* Participants is able to participate for the duration of the study\n\nExclusion Criteria\n\n* Participant is not willing to provide written informed consent\n* Participant is unable to read and comprehend written and spoken English\n* Participant is \\< 18 years of age\n* Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)\n* Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months\n* Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated\n* Participant is unable to participate for the duration of the study\n* Participant is pregnant\n* Participant is established on bi-level support therapy\n* Participant, or participants bed partner, has metallic implants in head neck or chest\n* Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (\\< 2years) case of pneumonia or lung infection, lung injury)\n* Participant is unsuitable to participate in the study in the opinion of the researcher'}, 'identificationModule': {'nctId': 'NCT02535234', 'briefTitle': 'Comparison of Two Continuous Positive Airway Pressure Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.', 'orgStudyIdInfo': {'id': 'MA011015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system', 'interventionNames': ['Device: Novel System', 'Device: Traditional System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system', 'interventionNames': ['Device: Novel System', 'Device: Traditional System']}], 'interventions': [{'name': 'Novel System', 'type': 'DEVICE', 'description': 'A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Traditional System', 'type': 'DEVICE', 'otherNames': ['AirSense System'], 'description': 'A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2153', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'ResMed', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Klaus Schindhelm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ResMed Limited'}, {'name': 'Holger Woehrle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ResMed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}