Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT03816566
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2019-01-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Wearable Non-invasive Device (the Patch)
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': 'D057968', 'term': 'Transdermal Patch'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The outcome assessor performing the automatic analysis of the patch data will be blinded to the PSG scores performed by the Sleep Lab Technicians.\n\nThe principal investigator responsible for the completion and closing of the study according to the protocol will be blinded to the patch AHI automatic analysis.\n\nSimilarly, the Sleep Lab Technicians scoring the PSG will be blinded to the patch automatic analysis.\n\nBy the end of recruiting the target sample size, the data will be un-blinded and statistical analysis will be performed.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-08-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-23', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of AHI', 'timeFrame': '8 months', 'description': 'Validate the performance of the patch in estimating the AHI compared to an in-laboratory PSG.'}], 'secondaryOutcomes': [{'measure': 'Estimation of body position', 'timeFrame': '8 months', 'description': 'Validate the performance of the patch in estimating body position during sleep compared to an in-laboratory PSG.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'BresoTEC has designed and developed a standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject.', 'detailedDescription': 'The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy. We have developed advanced signal processing algorithms to detect apneas and hypopneas. Many of these techniques for analyzing breathing sounds and detecting apneas and hypopneas have been published in peer-reviewed journals.\n\nThe goal of this study is to validate the patch against polysomnography (PSG) for use as an aid in the diagnosis of sleep apnea for adult patients. Our primary objective is to assess whether the estimated apnea-hypopnea index (AHI) calculated by the patch agrees with the results of an in-laboratory PSG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria are men and women 18 years and above, who are referred to either the University Health Network (UHN), Toronto Rehabilitation Institute (TRI) or Toronto General Hospital sleep laboratories for overnight PSG because of a suspicion of a sleep disorder. It is intended for the general outpatient population.\n\nExclusion Criteria:\n\n* Exclusion criteria are patients with suspected complicated co-morbidities including in-hospital patients and those who self-report diagnosis of heart failure, recent stroke, neuromuscular disorders, renal failure, obesity hypoventilation, COPD, or other severe lung diseases.'}, 'identificationModule': {'nctId': 'NCT03816566', 'briefTitle': 'Validation of a Wearable Non-invasive Device (the Patch)', 'organization': {'class': 'INDUSTRY', 'fullName': 'BresoTEC Inc.'}, 'officialTitle': 'Validation of a Wearable Non-invasive Device (the Patch) to Aid in Diagnosing Sleep Apnea', 'orgStudyIdInfo': {'id': 'CL-00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearable Device and PSG', 'description': 'The device under investigation (the patch) will be used in patients undergoing overnight polysomnography simultaneously, to compare the accuracy of the investigational device against the gold standard for the diagnosis of sleep apnea.', 'interventionNames': ['Device: patch']}], 'interventions': [{'name': 'patch', 'type': 'DEVICE', 'description': 'A standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject. The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy.', 'armGroupLabels': ['Wearable Device and PSG']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2A2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Clodagh Ryan, MD', 'role': 'CONTACT', 'email': 'Clodagh.Ryan@uhn.ca', 'phone': '416 340 4719'}, {'name': 'Clodagh Ryan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Clodagh Ryan, MD', 'role': 'CONTACT'}, {'name': 'Clodagh Ryan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Hisham Alshaer, MD, PhD', 'role': 'CONTACT', 'email': 'Hisham.Alshaer@uhn.ca', 'phone': '416-597-3422', 'phoneExt': '7959'}], 'overallOfficials': [{'name': 'Clodagh Ryan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital & Toronto Rehabilitation Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BresoTEC Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}