Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-04 @ 8:44 PM
Study NCT ID:
NCT03017859
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea
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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-09', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent rapid eye movement (REM) sleep', 'timeFrame': 'During at least 2 hours of sleep time'}, {'measure': 'Percent Deep sleep', 'timeFrame': 'During at least 2 hours of sleep time'}, {'measure': 'User experience with HFNC', 'timeFrame': 'During at least 2 hours of sleep time', 'description': 'To be assessed in the following morning with questionnaires'}], 'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index (AHI)', 'timeFrame': 'During at least 2 hours of sleep time', 'description': 'Comparison of HFNC AHI to baseline AHI and to CPAP AHI'}], 'secondaryOutcomes': [{'measure': 'Percent of hypoxemia time', 'timeFrame': 'During at least 2 hours of sleep time', 'description': 'O2 saturation (SO2)\\<90% as measured by pulse oximeter'}, {'measure': 'Minimal SO2%', 'timeFrame': 'During at least 2 hours of sleep time'}, {'measure': 'Adverse events reported while using HFNC', 'timeFrame': 'During at least 2 hours of sleep time'}, {'measure': 'Sleep efficiency', 'timeFrame': 'During at least 2 hours of sleep time'}, {'measure': 'Total sleep time', 'timeFrame': 'During at least 2 hours of sleep time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'A single center, prospective study to assess the efficacy of high flow nasal cannula (HFNC) in improving obstructive sleep apnea (OSA) parameters in patients with reduced tolerance to continuous positive airway pressure (CPAP) treatment.', 'detailedDescription': 'A single center, prospective study. The study would include 30 patients diagnosed within the past 2 years with moderate to severe OSA (AHI\\>=15) at the Rabin Medical Center (RMC) sleep lab, and who are intolerant to CPAP treatment. Following signing an informed consent form, these patients would undergo polysomnography (PSG) while treated with HFNC. The HFNC PSG outcome measures will be compared to the baseline PSG done within the past 2 years and to an additional PSG while connected to a CPAP device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Confirmed diagnosis of obstructive sleep apnea, diagnosed at RMC sleep lab in the past 2 years\n* Apnea Hypopnea Index (AHI)≥15\n* Patient has difficulties to adjust or comply with CPAP treatment\n* Signed Informed Consent Form\n\nExclusion Criteria:\n\n* Patients who need bilevel positive airway pressure (BIPAP)\n* Known carbon dioxide (CO2) retainers\n* Weight change\\>10% compared to time of OSA diagnosis\n* Clinically unstable patients\n* Pregnant women or special populations (e.g. children or patients unable to give informed consent)'}, 'identificationModule': {'nctId': 'NCT03017859', 'briefTitle': 'High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'High Flow Nasal Cannula as a Treatment for Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'RMC-16-0152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High flow nasal cannula treatment', 'description': 'Airvo 2 device will be used to administer high flow air during the night', 'interventionNames': ['Device: High flow nasal cannula']}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'DEVICE', 'description': 'We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.', 'armGroupLabels': ['High flow nasal cannula treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Avraham Unterman, MD', 'role': 'CONTACT', 'email': 'ramiun@clalit.org.il', 'phone': '972-39377221'}], 'overallOfficials': [{'name': 'Mordechai R Kramer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Institute, Rabin Medical Center, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Pulmonary Institute', 'investigatorFullName': 'Mordechai Kremer', 'investigatorAffiliation': 'Rabin Medical Center'}}}}