Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-05 @ 6:09 AM
Study NCT ID:
NCT06514833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors responsible for conducting the neurodevelopment tests are blinded to the group allocation.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2028-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bayley Scales of Infant and Toddler Development score', 'timeFrame': 'Children at 24 months', 'description': 'The Bayley Scales of Infant and Toddler Development (Bayley-III) evaluates five key developmental domains:\n\n1. Cognitive Development.\n2. Language Development.\n3. Motor Development.\n4. Social-Emotional Development.\n5. Adaptive Behavior.'}], 'secondaryOutcomes': [{'measure': 'Ages and Stages Questionnaires (ASQ) score', 'timeFrame': 'Children at 12 months', 'description': 'ASQ typically evaluates the following areas:\n\n1. Communication.\n2. Gross Motor.\n3. Fine Motor.\n4. Problem Solving.\n5. Personal-Social.'}, {'measure': 'Ages and Stages Questionnaires (ASQ) score', 'timeFrame': 'Children at 6 months', 'description': 'ASQ typically evaluates the following areas:\n\n1. Communication.\n2. Gross Motor.\n3. Fine Motor.\n4. Problem Solving.\n5. Personal-Social.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep disturbance', 'Neurodevelopment'], 'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'To examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances. These women will receive lifestyle recommendations to nap regularly and will choose whether or not to nap. The participants will wear wrist-worn accelerometers to record their 24-hour sleep patterns for seven consecutive days during the early, middle, and late stages of pregnancy. The neurodevelopment of their offspring will be assessed at 6 months, 12 months, 18 months, and 2 years of age.', 'detailedDescription': "Participants will be recruited based on the Early Life Plan Project, an ongoing hospital-based prospective birth cohort study. Pregnant women will be recruited at the time of booking for prenatal care. The sleep patterns of pregnant women will be assessed at 12-16 weeks of gestation using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Women with a PSQI score greater than 5 and who self-report as not being habitual nappers in the last 3 months will be recruited. These women will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00. Whether they adopt this lifestyle change or the actual duration of their naps will be entirely up to the participants. An Actiwatch will be given to the participants during early pregnancy (12-14 weeks), mid-pregnancy (22-24 weeks), and late pregnancy (29-32 weeks). Instructions will be included on how to wear the watch, with participants advised to wear it on the non-dominant wrist continuously for 7 days, except when swimming or bathing. In addition to the Actiwatch, participants will complete a sleep questionnaire during early pregnancy (12-14 weeks), mid-pregnancy (26-27 weeks), and late pregnancy (35-37 weeks) to subjectively assess their nighttime sleep and napping over the past month. The neurodevelopment of the participants' offspring will be followed up and assessed using the Bayley Scales of Infant and Toddler Development at 6 months, 12 months, 18 months, and 2 years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant women with a PSQI score greater than 5 at enrollment.\n2. Not a habitual napper in the past 3 months (defined as napping 5 or more days per week on average for the past month).\n\nExclusion Criteria:\n\nWomen with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.'}, 'identificationModule': {'nctId': 'NCT06514833', 'briefTitle': 'Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment', 'orgStudyIdInfo': {'id': 'XH-24-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nap', 'description': 'The experimental group will receive lifestyle recommendations to nap regularly', 'interventionNames': ['Behavioral: lifestyle recommendations to nap regularly']}, {'type': 'OTHER', 'label': 'No nap', 'description': 'The control group would not receive lifestyle recommendations to nap regularly', 'interventionNames': ['Other: No recommendations to nap regularly']}], 'interventions': [{'name': 'lifestyle recommendations to nap regularly', 'type': 'BEHAVIORAL', 'description': 'Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00', 'armGroupLabels': ['Nap']}, {'name': 'No recommendations to nap regularly', 'type': 'OTHER', 'description': 'No lifestyle recommendations to nap regularly', 'armGroupLabels': ['No nap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Guangyu Chen, Ph.D.', 'role': 'CONTACT', 'phone': '86-21-25077485'}], 'facility': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yun Huang, Ph.D.', 'role': 'CONTACT', 'email': 'yunhuang.pku@gmail.com', 'phone': '86-021-25078999'}], 'overallOfficials': [{'name': 'Yun Huang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital Affiliated to Shanghai Jiao Tong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}