Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-21 @ 4:03 AM
Study NCT ID:
NCT02369705
Status:
COMPLETED
Last Update Posted:
2016-07-15
First Post:
2015-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2015-02-08', 'studyFirstSubmitQcDate': '2015-02-23', 'lastUpdatePostDateStruct': {'date': '2016-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the WP200 and WP200U in assessing RDI, AHI, sleep stages compared to the "gold standard" - PSG', 'timeFrame': 'Within 1 year after data collection is complete.', 'description': 'calculation of the sensitivity, specificity, agreement and correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the "gold standard" disorders for subjects with cardiac disorders and/or comorbidities, to the manual scoring of the PSG that serves as a "gold standard".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'Subjects with cardiac disorders will be tested in the sleep laboratory with a conventional full-night PSG recording along with WP 200/WP200U ambulatory sleep diagnostic device in a synchronized manner.\n\nThe PSG data will be scored manually by a trained polysomnographic scorer, according to standard criteria for this clinical routine.\n\nThe data obtained by the WP200/WP200U will be analyzed automatically for RDI, AHI, sleep stages, snoring (optional) and body position (optional), in addition to parameters specific to cardiac subjects. The analysis will be performed by the WP200/WP200U software (zzzPAT) and will be compared to the PSG\'s manual scoring which serves as a "Gold Standard".', 'detailedDescription': "Subjects with cardiac disorders, referred to the sleep lab will be offered to participate in the study. Subjects will be asked to sign an informed consent form and will be screened for inclusion exclusion criteria.\n\nSubject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate pre-study electronic case report forms.\n\nThe subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP 200/WP200U wrist device, which includes the PAT and pulse oximeter probes will be worn on the wrist.\n\nThe investigator will not have access to the WP200/WP200U data while scoring the PSG data. During the study recording, the WP200/WP200U data will be recorded inside the device, without being displayed on the PSG monitor. Furthermore, the WP200/WP200U analysis is done automatically without knowledge of the PSG scoring results."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with cardiac disorder, referred to the sleep lab for a night study, who consent to undergo an overnight sleep study in the clinical sleep laboratory.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between17-90\n* Subject is able to read understand and sign the informed consent form.\n* Subject with diagnosed cardiac disorders and/or other comorbidity\n* Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab\n\nExclusion Criteria:\n\n* Permanent pacemaker: atrial pacing or VVI without sinus rhythm\n* Finger deformity that precludes adequate sensor appliance.\n* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)'}, 'identificationModule': {'nctId': 'NCT02369705', 'briefTitle': 'Validation of Ambulatory Sleep Test (WP200/U) Compared In-lab Sleep Testing in Cardiac Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Itamar-Medical, Israel'}, 'officialTitle': 'Diagnosis of Sleep-related Respiratory Disorders in Patients With Cardiac Disorders Such as Atrial Fibrillation, Heart Failure and Other Comorbidities', 'orgStudyIdInfo': {'id': 'WP200/U-Cardio-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '95864', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Fontana', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida'}, {'city': 'Smithtown', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook medical center sleep lab', 'geoPoint': {'lat': 40.85593, 'lon': -73.20067}}, {'zip': 'M3N 1X1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for sleep and Chronobiology', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Ichilov Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Thomas Penzel, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}, {'name': 'Richard Berry, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Itamar-Medical, Israel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}