Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00425659
Status:
COMPLETED
Last Update Posted:
2009-07-10
First Post:
2007-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-09', 'studyFirstSubmitDate': '2007-01-22', 'studyFirstSubmitQcDate': '2007-01-22', 'lastUpdatePostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity of the new home sleep study device compare with conventional inpatient sleep study', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The relative efficacy between different algorithm', 'timeFrame': '1 year'}, {'measure': 'Failure rates in different algorithms which need to switch to the conventional algorithm', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Health utility', 'Home sleep study'], 'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients', 'detailedDescription': 'Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.\n\nHypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.\n\nStudy instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.\n\nInterventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.\n\nMain outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with high pretest probability of OSAS, i.e. ESS \\> 10 or symptomatic patients, with BMI \\> 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.\n* Patients aged between 18-65 years who agree to participate in the study.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients who refuse signing consent of the study\n* Do not have high pretest probability of OSAS\n* Refuse to have home sleep study\n* Refuse any treatment offered; or\n* Could not comply with the set up of home study.'}, 'identificationModule': {'nctId': 'NCT00425659', 'briefTitle': 'Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong', 'orgStudyIdInfo': {'id': 'CRE-2006.404-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Device: home CPAP titration (Autoset)']}, {'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: home sleep study']}, {'type': 'OTHER', 'label': '2', 'description': 'usual practice', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'home sleep study', 'type': 'DEVICE', 'otherNames': ['different algorithm arrangement'], 'description': 'different in algorithm arrangement for diagnosing sleep apnea', 'armGroupLabels': ['1']}, {'name': 'home CPAP titration (Autoset)', 'type': 'DEVICE', 'otherNames': ['Autoset'], 'description': 'continuous positive airway pressure device for treatment of sleep apnea', 'armGroupLabels': ['3']}, {'name': 'CPAP', 'type': 'DEVICE', 'description': 'usual practice', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kin W To, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Doctor', 'oldOrganization': 'CUHK'}}}}