Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT01395693
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2011-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance of the Salt Lake Mask 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-19', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-07-14', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.', 'timeFrame': '1 week', 'description': 'Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.'}], 'secondaryOutcomes': [{'measure': 'Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly', 'timeFrame': '1 week', 'description': 'Participants in the study will subjectively assess the ease and intuitiveness of specific common assembly/diosassembly tasks related to the Salt Lake mask system.'}, {'measure': 'Subjectively Assessed Levels of Skin Markings', 'timeFrame': '1 week', 'description': 'Participants in the study will subjectively assess the levels of Skin Markings experienced as a direct result of use of the Salt Lake mask system.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.', 'detailedDescription': 'Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.\n\nIn order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], '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 using the Swift FX mask system\n* Patients who can trial the mask for 7 nights\n* Patients who have used PAP therapy for a minimum of 6 months.\n\nExclusion Criteria:\n\n* Patients not willing to give written informed consent\n* Patients who can not read and comprehend English\n* Patients using an inappropriate mask system\n* Patients using Bilevel flow generators\n* Patients who are pregnant\n* Patients who are unable to comply with the protocol\n* Patients who have used PAP therapy for less than 6 months.'}, 'identificationModule': {'nctId': 'NCT01395693', 'briefTitle': 'Performance of the Salt Lake Mask System', 'organization': {'class': 'INDUSTRY', 'fullName': 'ResMed'}, 'officialTitle': 'Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy', 'orgStudyIdInfo': {'id': 'MA200611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salt Lake mask system', 'interventionNames': ['Device: Salt Lake mask system']}], 'interventions': [{'name': 'Salt Lake mask system', 'type': 'DEVICE', 'otherNames': ['Salt Lake'], 'description': 'Study participants will Salt Lake mask system for 1 week in place of their current mask system.', 'armGroupLabels': ['Salt Lake mask system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2153', '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'}}}}