Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01752556
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2012-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of Home Respiratory Polygraphy
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2012-05-17', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up.', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.', 'timeFrame': 'Six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep apnea, Portable monitor,autoCPAP'], 'conditions': ['Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '28636405', 'type': 'DERIVED', 'citation': 'Corral J, Sanchez-Quiroga MA, Carmona-Bernal C, Sanchez-Armengol A, de la Torre AS, Duran-Cantolla J, Egea CJ, Salord N, Monasterio C, Teran J, Alonso-Alvarez ML, Munoz-Mendez J, Arias EM, Cabello M, Montserrat JM, De la Pena M, Serrano JC, Barbe F, Masa JF; Spanish Sleep Network. Conventional Polysomnography Is Not Necessary for the Management of Most Patients with Suspected Obstructive Sleep Apnea. Noninferiority, Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1181-1190. doi: 10.1164/rccm.201612-2497OC.'}]}, 'descriptionModule': {'briefSummary': 'Primary objectives:\n\nThe efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale;\n\nSecondary Objective:\n\n1. the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D.\n2. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques', 'detailedDescription': 'Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Snoring or sleep apneas observed by partner\n2. Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10\n3. Age between 18 and 70\n4. Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness\n\nExclusion criteria:\n\n1. Psycho-physical inability to complete questionnaires\n2. documented structural or coronary cardiopathy not controlled by medical treatment\n3. Cheyennes-Stokes Syndrome\n4. Patient has undergone an uvulopalatopharyngoplasty\n5. Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT01752556', 'acronym': 'HRP-M', 'briefTitle': 'Cost-effectiveness of Home Respiratory Polygraphy', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Española de Neumología y Cirugía Torácica'}, 'officialTitle': 'Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome', 'orgStudyIdInfo': {'id': 'PI12/01240'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hospital diagnosis', 'description': 'diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography', 'interventionNames': ['Procedure: diagnosis and therapeutic decision']}, {'type': 'EXPERIMENTAL', 'label': 'Home diagnosis', 'description': 'diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy', 'interventionNames': ['Procedure: diagnosis and therapeutic decision']}], 'interventions': [{'name': 'diagnosis and therapeutic decision', 'type': 'PROCEDURE', 'description': 'A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths', 'armGroupLabels': ['Hospital diagnosis']}, {'name': 'diagnosis and therapeutic decision', 'type': 'PROCEDURE', 'description': 'A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months', 'armGroupLabels': ['Home diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10005', 'city': 'Cáceres', 'state': 'Cáceres', 'country': 'Spain', 'facility': 'Juan F. Masa', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}], 'overallOfficials': [{'name': 'Juan F. Masa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Pedro de Alcántara. Cáceres. Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Española de Neumología y Cirugía Torácica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Juan F. Masa', 'investigatorAffiliation': 'Sociedad Española de Neumología y Cirugía Torácica'}}}}