Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04419051
Status:
UNKNOWN
Last Update Posted:
2020-10-01
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gather information', 'timeFrame': 'From date of enrollment until the date of reported delivery or early termination , whichever came first, assessed up to 16 weeks', 'description': 'Successful collection of Owlet Band data from study participants'}, {'measure': 'Gather information', 'timeFrame': 'Up to 16 weeks', 'description': 'Completion of study questionnaires by at least 500 participants'}], 'secondaryOutcomes': [{'measure': 'Management of anxiety State Trait Anxiety Inventory', 'timeFrame': 'Participant completion of the STAI questionnaire before wearing the Owlet Band and at Day 31 (+3 days)', 'description': 'Change in anxiety as assessed by State Trait Anxiety Inventory (STAI)'}, {'measure': 'Management of stress (Perceived Stress Scale)', 'timeFrame': 'Participant completion of the PSS questionnaire before wearing the Owlet Band and at Day 31 and Day 52 (+3 days)', 'description': 'Change in perceived stress as assessed by Perceived Stress Scale (PSS)'}, {'measure': "Participant's experience while using the Owlet Band", 'timeFrame': 'Through study completion, up to 16 weeks', 'description': 'Self-report of bonding and connection'}, {'measure': 'Maintenance of standard medical care', 'timeFrame': 'Through study completion, up to 16 weeks', 'description': 'Self-Report of standard medical care and unexpected or unscheduled visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Owlet', 'Pregnancy', 'Digital Health', 'Wellness'], 'conditions': ['Pregnancy', 'Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': "This is an observational research study of a new pregnancy tracker used to gather information about a pregnant woman's general wellness.", 'detailedDescription': 'The Owlet Band is a wellness product (similar to a fitbit), it is not designed to be a "medical device". The study involves women age 18 and older who are currently pregnant, at least 24 weeks\' gestation or later, and who live in the USA. Up to 8,000 pregnant women are expected to participate in the study. This study will involve review of Owlet Band data and participant responses to questionnaires throughout the study. The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pregnant women 24 weeks' gestation and later", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be at least 24 weeks pregnant with a singleton pregnancy\n* Must be at least 18 years of age\n* Must currently live in the United States\n* Must have a compatible smartphone (Apple iOS Version 13 or above)\n* Able to read and understand English in order to provide Informed Consent and follow study instructions\n\nExclusion Criteria:\n\n* NA'}, 'identificationModule': {'nctId': 'NCT04419051', 'briefTitle': 'Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Owlet Baby Care, Inc.'}, 'officialTitle': 'Owlet Band Observational Study: Observe the Use of a New Pregnancy Tracker for Expecting Mothers', 'orgStudyIdInfo': {'id': 'OWLB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Owlet Band', 'type': 'OTHER', 'description': "The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart."}]}, 'contactsLocationsModule': {'locations': [{'zip': '84043', 'city': 'Lehi', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Kenley, BS, CCRC', 'role': 'CONTACT', 'email': 'mkenley@owletcare.com', 'phone': '801-552-8383'}, {'name': 'Kenneth Ward, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Owlet Baby Care, Inc.', 'geoPoint': {'lat': 40.39162, 'lon': -111.85077}}], 'centralContacts': [{'name': 'Madison Kenley, BS, CCRC', 'role': 'CONTACT', 'email': 'mkenley@owletcare.com', 'phone': '801-783-3522'}, {'name': 'Kenneth Ward, MD', 'role': 'CONTACT', 'email': 'kward@owletcare.com', 'phone': '801-783-3522'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Owlet Baby Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}