Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-31 @ 2:13 PM
Study NCT ID:
NCT04366193
Status:
UNKNOWN
Last Update Posted:
2020-04-28
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-resolution Oximetry to Diagnose 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010092', 'term': 'Oximetry'}], 'ancestors': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of high-resolution oximetry for OSA', 'timeFrame': 'single night', 'description': 'Accuracy will be tested against home sleep test using ROC, sensitivity and specificity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep apnea', 'home sleep test', 'oximetry'], 'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare an overnight digital monitoring device (ODM) with home sleep apnea testing (HSAT) using respiratory flow and effort parameters in a large population sample, who were in a waiting list for Polysomnography (PSG).', 'detailedDescription': 'Obstructive Sleep Apnea (OSA) is extremely common has prompted the popularization of home sleep test (HST). HST record a limited number of respiratory signals, provide a more comfortable testing option to the patient at a lower cost. HST has a performance as good as PSG among patients with suspected OSA and no significant co-morbidities.\n\nOur study was designed to investigate the performance of a simple solution that consists of a high-resolution wireless oximeter with a built-in accelerometer linked to a smartphone application and automated cloud algorithm for detection of oxygen desaturation, described herein as Overnight Digital Monitoring (ODM) (BilogixTM). We will compare the results of ODM with HST performed by ApneaLink Air by Resmed®.\n\nWe have already compared ODM to PSG with excellent results in a prior study and intend to see the results in uncontrolled environment (home) .\n\nPopulation: Men and women from the São Paulo Department of Health, who are awaiting examination for diagnosis of OSAS.We intend to compare the ODM with the HST. Patients with indication for CPAP titration will be excluded. The participants will wear a wireless oximeter (Oxistar, Biologix Sistemas Ltda., Brazil) with a built-in accelerometer on a finger of the same hand as the HST oximeter and we will compare both methods for diagnosing OSA.\n\nAll HST studies will be scored by 2 independent certified technicians blinded to the ODM results. Hypopnea will be defined as a peak signal excursion drop by ≥ 30% of pre-event baseline nasal pressure signal lasting ≥ 10 sec. Hypopneas will be scored according the acceptable AASM criteria for hypopnea (≥ 4% reduction in SpO2). Mild, moderate and severe OSA will be defined according to the current standards (5 ≤ AHI \\<15; 15 ≤ AHI \\<30 and AHI ≥30 events/h, respectively).ODI results from ODM will be expressed as the number of desaturations per recording time and will be automatically analyzed at the cloud. In order to compare with TST-AHI4%, ODM will be matched using 4% desaturation criteria (ODM-ODI4%, respectively).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ambulatory patients who are in a waiting list for polysomnography', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ambulatory patients who are in a waiting list for polysomnography that are able to properly place the oximeter and home sleep test at home\n\nExclusion Criteria:\n\n* patients under treatment for OSA'}, 'identificationModule': {'nctId': 'NCT04366193', 'briefTitle': 'High-resolution Oximetry to Diagnose Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Validation of a High-resolution Oximeter Using a Cloud-based Algorithm to Diagnose Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '3767871'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oximetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Validation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Pedro R Genta, MD', 'role': 'CONTACT', 'email': 'prgenta@gmail.com', 'phone': '551126625486'}], 'facility': 'Sleep Laboratory, Heart Institute, Pulmonary Division, Hospital das Clínicas da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Geraldo Lorenzi Filho', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}