Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-01 @ 5:41 PM
Study NCT ID:
NCT01590420
Status:
UNKNOWN
Last Update Posted:
2012-05-03
First Post:
2012-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-02', 'studyFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2012-05-02', 'lastUpdatePostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'costs of medical events post CPAP treatment', 'timeFrame': '3 years', 'description': 'To evaluate the health satuts costs post-CPAP treatment.'}, {'measure': 'Number of hospitalizations', 'timeFrame': '3 years'}, {'measure': 'Changes in medications', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Costs relative to CPAP treatment', 'timeFrame': '3 years', 'description': 'To evaluate the influence of CPAP device on directs health costs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['OSA', 'Sleep', 'CPAP', 'Cost'], 'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the cost-utility of continuous positive airway pressure (CPAP) therapy in obstructive sleep apnea (OSA) patients in Sao Paulo city, Brazil, after 3 years of treatment and to estimate the cost-effectiveness of CPAP on the number of medical visits, hospitalizations, medical examinations, used medications, new case incidence and cost of traffic accidents and absence from work. It is also designed to estimate quality-adjusted extended years of life, and to assess cost-effects of the therapy (device, masks, supplies, maintenance/year for membership of professional consulting, electric power) on the cost-effectiveness', 'detailedDescription': 'OSA is highly prevalent in Sao Paulo city, Brazil. It is associated with significant comorbidities. The cost-utility study is important to (1) support decision-making on health policies, (2) to incorporate new technologies, (3) implementation of preventive programs and policy development assistance in the medical field.\n\nProbably CPAP treatment in the long-term, will improve health, physical and mental state, and especially, reduces spending on public health, demonstrating cost-utility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Aged 30 to 70 years old\n* AHI \\> 30 events/hour\n\nExclusion Criteria:\n\n* Patients residing in other cities and states other than São Paulo / SP / Brazil\n* Patients with no fixed residence\n* Previous CPAP contact'}, 'identificationModule': {'nctId': 'NCT01590420', 'briefTitle': 'Cost-utility Study of Continuous Positive Airway Pressure Treatment in Obstructive Sleep Apnea Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Associação Fundo de Incentivo à Pesquisa'}, 'officialTitle': 'Cost-utility Study of CPAP Treatment in Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'Cost-utility of OSAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP treatment', 'description': '1000 patients with 3-years CPAP treatment after a PSG titration', 'interventionNames': ['Device: CPAP S8- Scape / Resmed']}], 'interventions': [{'name': 'CPAP S8- Scape / Resmed', 'type': 'DEVICE', 'otherNames': ['S8 Escape', 'Resmed'], 'description': 'The pressure for treatment is according to PSG titration', 'armGroupLabels': ['CPAP treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04024-002', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Camila F Rizzi, PhD', 'role': 'CONTACT', 'email': 'camila.rizzi@unifesp.br', 'phone': '+55 (11) 85555049'}, {'name': 'Camila F Rizzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Associação Fundo de Incentivo à Pesquisa', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Camila F Rizzi, PhD', 'role': 'CONTACT', 'email': 'camila.rizzi@unifesp.br', 'phone': '+55 (11) 85555049'}, {'name': 'Dalva Poyares, PhD', 'role': 'CONTACT', 'email': 'poyares@unifesp.br', 'phone': '+55 (11) 85937418'}], 'overallOfficials': [{'name': 'Camila F Rizzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Dalva Poyares, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Sergio Tufik, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Federal University of São Paulo'}, {'name': 'Marcos F Bosi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Camila Furtado Rizzi', 'investigatorAffiliation': 'Associação Fundo de Incentivo à Pesquisa'}}}}