Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-24 @ 10:22 PM
Study NCT ID:
NCT02152566
Status:
TERMINATED
Last Update Posted:
2016-02-08
First Post:
2014-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rachel.vicars@fphcare.co.nz', 'phone': '09 574 0123', 'title': 'Dr Rachel Vicars', 'phoneExt': '7759', 'organization': 'Fisher & Paykel Healthcare'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy', 'description': 'All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.\n\nNasal High flow therapy device: Nasal high flow therapy via nasal cannula.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy', 'description': 'All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.\n\nNasal High flow therapy device: Nasal high flow therapy via nasal cannula.'}], 'timeFrame': 'During 1 night of Sleep on PSG', 'description': 'The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy', 'description': 'All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.\n\nNasal High flow therapy device: Nasal high flow therapy via nasal cannula.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy', 'description': 'All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.\n\nNasal High flow therapy device: Nasal high flow therapy via nasal cannula.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '8.73', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'From the 6 participants, 2 withdrew consent before participating in the study. 1 was lost to follow up as the participant did not turn up to his appointment.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Difficulty with recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2014-05-29', 'resultsFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2014-05-29', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-19', 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Efficacy', 'timeFrame': 'During 1 night of Sleep on PSG', 'description': 'The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sleep Disordered Breathing', 'Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.\n\nThe purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen.\n\nHeart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and Women aged ≥ 18 years\n* Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months\n* Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.\n* New York Heart Association Class II or III after optimization of medical therapy\n* Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry\n\nExclusion Criteria:\n\n* Unstable angina\n* Myocardial infarction within the last 12 months\n* Cardiac surgery within the previous 6 months\n* Pregnancy\n* Unwilling or unable to provide informed consent\n* Uncontrolled arrhythmias\n* Severe valvular heart disease\n* Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT02152566', 'briefTitle': 'Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.', 'orgStudyIdInfo': {'id': 'CIA-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic PSG/PG, PSG w. nasal high flow therapy', 'description': 'All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies with Cheyne-Stokes respiration (CSR) are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.', 'interventionNames': ['Device: Nasal High flow therapy device']}], 'interventions': [{'name': 'Nasal High flow therapy device', 'type': 'DEVICE', 'description': 'Nasal high flow therapy via nasal cannula.', 'armGroupLabels': ['Diagnostic PSG/PG, PSG w. nasal high flow therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1010', 'city': 'Auckland', 'state': 'East Tamaki', 'country': 'New Zealand', 'facility': 'Fisher & Paykel Healthcare Ltd.', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '2025', 'city': 'Auckland', 'state': 'Otahuhu', 'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'overallOfficials': [{'name': 'Rachel Vicars, PhD - Eng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fisher & Paykel Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}