Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT03489460
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2018-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Exploring Sleep Education & Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1060}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-29', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep time measured by wearable mobile sleep tracking technology', 'timeFrame': '15 Days', 'description': 'Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients'}, {'measure': 'Time in deep sleep measured by wearable mobile sleep tracking technology', 'timeFrame': '15 Days', 'description': 'Mobile sleep tracking device will be worn by patient for 15 days and will measure sleep patterns in patients'}, {'measure': 'Dysfunctional Beliefs about Sleep (DBAS) scale', 'timeFrame': '1 Day', 'description': '24-item DBAS scale with five subscales corresponding to: (1) consequences of insomnia (2) control and predictability of sleep (3) sleep requirement expectations (5) sleep-promoting practices'}, {'measure': 'Measure of motivation to change using the Change Assessment Scale (CAS)', 'timeFrame': '15 Days', 'description': '8 scale measure divided into 4 separate scales: Scale 1: "Pre-Contemplation" Scale 2: "Contemplation" Scale 3 "Action" Scale 4 "Maintenance"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep health'], 'conditions': ['Sleep Health']}, 'descriptionModule': {'briefSummary': 'A pilot study that seeks to develop a set of typologies of users of mobile sleep tracking technologies, and optimal sleep health educational strategies among users of mobile wearable technologies that track sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A current user of the OURA ring activity and sleep tracker device.\n\nFor Aim 3 MOST message testing, the inclusion criteria include the following:\n\n* Health conscious.\n\nExclusion Criteria:\n\n* Non English speakers.'}, 'identificationModule': {'nctId': 'NCT03489460', 'acronym': 'RESET', 'briefTitle': 'Research Exploring Sleep Education & Technology', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Research Exploring Sleep Education & Technology', 'orgStudyIdInfo': {'id': '17-01591'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Receive sleep health messages + GAD', 'description': 'Procedures will be delivered to users of the GAD, individuals who have opted in via their smartphone application, to receive messages about various areas of health.', 'interventionNames': ['Behavioral: Specialized sleep-related message interventions', 'Behavioral: GAD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep message No GAD', 'description': 'For two weeks participants agree to receive sleep health messages and wear the GAD', 'interventionNames': ['Behavioral: Specialized sleep-related message interventions']}], 'interventions': [{'name': 'Specialized sleep-related message interventions', 'type': 'BEHAVIORAL', 'description': "Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.", 'armGroupLabels': ['Receive sleep health messages + GAD', 'Sleep message No GAD']}, {'name': 'GAD', 'type': 'BEHAVIORAL', 'description': 'Survey responses will be merged with objective GAD data (sleep time, time in deep sleep, physical activity) which will assist in developing message design formats for message testing.', 'armGroupLabels': ['Receive sleep health messages + GAD']}]}, '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': 'Girardin Jean-Louis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following publication. No end date', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Requests should be directed to Rebecca.robbins@nyulangone.org. To gain access, data requestors will need to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}