Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 6:46 PM
Study NCT ID:
NCT01171066
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2010-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2010-07-26', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'To assess the usability of the Tasman CPAP system', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': "Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.", 'detailedDescription': "Obstructive Sleep Apnoea (OSA) is a condition characterised by 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 positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.\n\nSome participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.\n\nThe purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.\n\nAim\n\n* To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)\n* To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients willing to give written informed consent\n* Patients who can read and comprehend English\n* Patients being treated for OSA for \\>6 months\n* Patients using a ResMed nasal mask system\n* Patients who can trial the trial mask for 7 nights\n\nExclusion Criteria\n\n* Patients not willing to give written informed consent\n* Patients who can not read and comprehend English\n* Patients being treated for OSA for \\<6 months\n* Patients using an inappropriate mask system\n* Patients using Bilevel flow generators\n* Patients who are not using CPAP between 7 and 13 cmH2O\n* Patients who are pregnant\n* Patients who cannot trial the trial mask for 7 nights\n* Patients with a hearing impairment'}, 'identificationModule': {'nctId': 'NCT01171066', 'briefTitle': 'Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'MA14010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tasman CPAP', 'interventionNames': ['Device: Tasman CPAP system']}], 'interventions': [{'name': 'Tasman CPAP system', 'type': 'DEVICE', 'otherNames': ['ResMed Tasman'], 'description': 'Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.', 'armGroupLabels': ['Tasman CPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2155', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'ResMed Ltd', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Klaus Schindhelm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ResMed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResMed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}