Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-27 @ 8:46 PM
Study NCT ID:
NCT00790166
Status:
TERMINATED
Last Update Posted:
2018-04-27
First Post:
2008-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2008-11-11', 'studyFirstSubmitQcDate': '2008-11-11', 'lastUpdatePostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mucociliary clearance.', 'timeFrame': 'pre and post cpap treatment with varying levels of humidity'}]}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) \\> 15\n* 75% of events during the diagnostic study must be obstructive\n\nExclusion Criteria:\n\n* Currently using CPAP treatment OR have used it in the past 4 weeks\n* Intolerance of CPAP and/or CPAP mask in the past or during the titration night\n* Mouth breather (unable to breath through mouth for the study period)\n* \\< 18years old\n* Nasal CPAP intolerance determined in the PSG-CPAP titration study\n* Serious nasal issues\n* Acute upper airway disease\n* Smoker\n* COPD\n* Congestive heart failure\n* Neuromuscular disease\n* Stroke'}, 'identificationModule': {'nctId': 'NCT00790166', 'acronym': 'CIA-6', 'briefTitle': 'Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fisher and Paykel Healthcare'}, 'officialTitle': 'Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'OSA CPAP,ThemoSmartMCC, Brasil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP + ThermoSmart™ humidity', 'interventionNames': ['Device: CPAP + ThermoSmart™ humidity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP + Conventional humidity', 'interventionNames': ['Device: CPAP + Conventional humidity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPAP + No added humidity', 'interventionNames': ['Device: CPAP + No added humidity']}], 'interventions': [{'name': 'CPAP + ThermoSmart™ humidity', 'type': 'DEVICE', 'description': 'an absolute humidity (AH) of 28 mg/l +/- 2mg/l', 'armGroupLabels': ['CPAP + ThermoSmart™ humidity']}, {'name': 'CPAP + Conventional humidity', 'type': 'DEVICE', 'description': 'an absolute humidity (AH) of 18 mg/l +/- 2 mg/l', 'armGroupLabels': ['CPAP + Conventional humidity']}, {'name': 'CPAP + No added humidity', 'type': 'DEVICE', 'description': 'ambient humidity', 'armGroupLabels': ['CPAP + No added humidity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Geraldo Lorenzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}