Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-23 @ 4:10 AM
Study NCT ID:
NCT02744235
Status:
WITHDRAWN
Last Update Posted:
2017-04-27
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mainstream Sleep Tracking Devices vs Polysomnography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to move forward due to funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time it takes subject to fall asleep', 'timeFrame': 'Up to 3 Months'}, {'measure': 'Number of Minutes of Sleep', 'timeFrame': 'Up to 3 Months'}, {'measure': 'Number of Arousals', 'timeFrame': 'Up to 3 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Sleep Apnea', 'Severe Insomnia', 'Epileptiform Activity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing Polysomnography\n\nExclusion Criteria:\n\n* severe sleep apnea\n* severe insomnia with less than two hours of sleep per night\n* epileptiform activity\n* electrical status epilepticus of sleep'}, 'identificationModule': {'nctId': 'NCT02744235', 'briefTitle': 'Mainstream Sleep Tracking Devices vs Polysomnography', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Sensitivity and Specificity of Mainstream Sleep Tracking Devices Compared to Polysomnography', 'orgStudyIdInfo': {'id': '15-00071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients undergoing Polysomnography', 'interventionNames': ['Device: Polysomnography Data', 'Device: Jawbone UP®', 'Device: Fitbit Charge ®']}], 'interventions': [{'name': 'Polysomnography Data', 'type': 'DEVICE', 'armGroupLabels': ['Patients undergoing Polysomnography']}, {'name': 'Jawbone UP®', 'type': 'DEVICE', 'armGroupLabels': ['Patients undergoing Polysomnography']}, {'name': 'Fitbit Charge ®', 'type': 'DEVICE', 'armGroupLabels': ['Patients undergoing Polysomnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Alcibiades Rodriguez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}