Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-27 @ 7:47 AM
Study NCT ID:
NCT02463461
Status:
WITHDRAWN
Last Update Posted:
2017-05-10
First Post:
2015-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not sure if we are going to do this study now.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2015-01-13', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sleep time (TST)', 'timeFrame': '1 night', 'description': 'The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.'}], 'secondaryOutcomes': [{'measure': 'Wake After Sleep Onset (WASO)', 'timeFrame': '1 Year', 'description': '(Wake After Sleep Onset) Total minutes of wakefulness recorded after Sleep Onset, as scored by epochs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insomnia']}, 'descriptionModule': {'briefSummary': 'The primary objective of the proposed study is to investigate the agreement levels of modern and well-established actigraphy devices against PSG in healthy as well as patient populations for multiple sleep parameters across two study sites (Qatar and New York City).', 'detailedDescription': 'The importance of sleep upon physiological and psychological health has been extensively documented. It has been proposed that adequate sleep, as well as good sleep quality, is vital for wellbeing. (1). Some have suggested that sleep curtailment has paralleled the increased prevalence of cardiometabolic disease including obesity (2), type 2 diabetes mellitus (3, 4), hypertension (5, 6) and more. Sleep researchers face a major challenge since there are multiple methods for sleep assessment, all of which have advantages and disadvantages.Whilst polysomnography (PSG) is considered to be the gold standard for sleep assessment, there are some limitations including laboratory attendance for the participant and sleep scoring variance. Sleep questionnaires are widely utilized, particularly in large epidemiological studies, but are susceptible to inaccuracies and some have not been validated against PSG. Wrist actigraphy has provided researchers with an attractive equivalent and there are now multiple commercial manufacturers available. Actigraphic devices are usually worn on the non-dominant wrist and the instrument is used to monitor wrist movements through the use of an accelerometer and a memory chip. Wrist actigraphy is useful in the detection of sleep, wake, and activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Male or female. 18-80 years old\n\nExclusion Criteria:\n\n* Not attending a regularly scheduled Polysomnography test at Weill Cornell Medical College. Under 18 or over 80 years old. Pregnancy. Unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT02463461', 'briefTitle': 'Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Comparison Between Multiple Wrist-worn Actigraphy Devices and Polysomnography', 'orgStudyIdInfo': {'id': '1406015180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ActiSleep Activity Monitor', 'description': 'Subjects placed in this group will given an ActiSleep Activity Monitor for the one night of the study.', 'interventionNames': ['Device: ActiSleep Activity Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Jawbone Activity Monitor', 'description': 'Subjects placed in this group will given a Jawbone Activity Monitor for the one night of the study.', 'interventionNames': ['Device: Jawbone Activity Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Actiwatch 2 Activity Monitor', 'description': 'Subjects placed in this group will given an Actiwatch 2 Activity Monitor for the one night of the study.', 'interventionNames': ['Device: Actiwatch 2 Activity Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'FitBit Activity Monitor', 'description': 'Subjects placed in this group will given a FitBit Activity Monitor for the one night of the study.', 'interventionNames': ['Device: FitBit Activity Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Actigraph by Ambulatory Monitoring Activity Monitor', 'description': 'Subjects placed in this group will given an Actigraph by Ambulatory Monitoring Activity Monitor for the one night of the study.', 'interventionNames': ['Device: Actigraph by Ambulatory Monitoring Activity Monitor']}], 'interventions': [{'name': 'ActiSleep Activity Monitor', 'type': 'DEVICE', 'description': 'Subjects in this group will wear a ActiSleep Activity Monitor.', 'armGroupLabels': ['ActiSleep Activity Monitor']}, {'name': 'Jawbone Activity Monitor', 'type': 'DEVICE', 'description': 'Subjects in this group will wear a Jawbone Activity Monitor.', 'armGroupLabels': ['Jawbone Activity Monitor']}, {'name': 'Actiwatch 2 Activity Monitor', 'type': 'DEVICE', 'description': 'Subjects in this group will wear a Actiwatch 2 Activity Monitor.', 'armGroupLabels': ['Actiwatch 2 Activity Monitor']}, {'name': 'FitBit Activity Monitor', 'type': 'DEVICE', 'description': 'Subjects in this group will wear a FitBit Activity Monitor.', 'armGroupLabels': ['FitBit Activity Monitor']}, {'name': 'Actigraph by Ambulatory Monitoring Activity Monitor', 'type': 'DEVICE', 'description': 'Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.', 'armGroupLabels': ['Actigraph by Ambulatory Monitoring Activity Monitor']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ana Krieger', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Weill Cornell Medical College in Qatar', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}