Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
Study NCT ID:
NCT04485728
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2020-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Improvement Intervention for Hospitalized Antepartum Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2020-07-21', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who use the sleep improvement intervention', 'timeFrame': 'Day 7'}, {'measure': 'Level of satisfaction with the intervention as assessed by a Likert assessment', 'timeFrame': 'Day 7', 'description': 'The scale ranges from 0-5 with 5 being extremely satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbance in Hospitalized Antepartum Patients']}, 'descriptionModule': {'briefSummary': 'This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* speak, read, and write English\n* medically stable\n* 20 weeks' gestation or greater\n* viable fetus\n* hospitalized at least 24 hours\n\nExclusion Criteria:\n\n* Do not speak, read, and write English\n* Medically unstable\n* Less than 20 weeks' gestation\n* Nonviable fetus\n* Hospitalized less than 24 hours"}, 'identificationModule': {'nctId': 'NCT04485728', 'briefTitle': 'Sleep Improvement Intervention for Hospitalized Antepartum Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sam Houston State University'}, 'officialTitle': 'Sleep Improvement Intervention for Hospitalized Antepartum Patients', 'orgStudyIdInfo': {'id': 'IRB-2020-83'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Improvement Intervention', 'interventionNames': ['Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care (Control)'}], 'interventions': [{'name': 'Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients', 'type': 'BEHAVIORAL', 'description': 'Patients are getting sleep hygiene education and a sleep hygiene kit.', 'armGroupLabels': ['Sleep Improvement Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Andrea M Smith, Ph.D., RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sam Houston State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sam Houston State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, {'name': 'Memorial Hermann Texas Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Andrea Smith', 'investigatorAffiliation': 'Sam Houston State University'}}}}