Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-02 @ 2:16 PM
Study NCT ID:
NCT06487650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development and Evaluation of Sleep Intervention for Perinatal Family
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety 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'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2024-06-13', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': "baseline, at 36-weeks' gestation, 2-week postpartum, 1-month, 3-month,6-month, and 12-month postpartum", 'description': 'The Chinese version of the Insomnia Severity Index (ISI) is used to measure the severity of insomnia symptoms, a higher score indicates more severe insomnia symptoms.'}], 'secondaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': "baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months", 'description': 'The 19-item Chinese version of the Pittsburgh Sleep Quality Index (PSQI), will be used to measure sleep quality and sleep disturbance, higher score indicates worse sleep quality'}, {'measure': 'Sleep duration using actigraphy', 'timeFrame': 'baseline, postpartum 1 month, 3 months, and 6 months.', 'description': 'The Actiwatch will be used to collect objective data of sleep duration'}, {'measure': 'Sleep sleep onset latency using actigraphy', 'timeFrame': 'baseline, postpartum 1 month, 3 months, and 6 months.', 'description': 'The Actiwatch will be used to collect objective data of sleep onset latency'}, {'measure': 'Sleep efficacy using actigraphy', 'timeFrame': 'baseline, postpartum 1 month, 3 months, and 6 months.', 'description': 'The Actiwatch will be used to collect objective data of sleep efficacy'}, {'measure': 'Wake after sleep onset using actigraphy', 'timeFrame': 'baseline, postpartum 1 month, 3 months, and 6 months.', 'description': 'The Actiwatch will be used to collect objective data of wake after sleep onset'}, {'measure': 'Infants sleep Questionnaire', 'timeFrame': 'postpartum 1 month, 3 months, 6 months, and 12-months', 'description': "Parents will be asked to rate their infant's sleep quality using the 19-item Brief Infant Sleep Questionnaire-Revised (BISQ-R). The BISQ will be used to assess sleep duration, duration of sleep by circadian rhythm, and night-time awakenings"}, {'measure': 'Depressive symptoms', 'timeFrame': "baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months", 'description': 'Maternal and paternal depressive symptoms will be assessed using the Taiwanese version of the 10-item Edinburgh Postnatal Depression Scale (EPDS), a higher score indicated more severe symptoms.'}, {'measure': 'Anxiety symptoms', 'timeFrame': "baseline, at 36-weeks' gestation, postpartum 1 month, 3 months, 6 months, and 12-months", 'description': 'The 20-item State Anxiety subscale of the State-Trait Anxiety Inventory (STAI) will be used to measure levels of anxiety symptoms in mothers and fathers, higher score presents more severe symptoms.'}, {'measure': 'Heart rate variability (HRV) measures', 'timeFrame': 'at baseline, postpartum 1 month, 3 months, and 6 months', 'description': 'The resting interbeat interval will be recorded'}, {'measure': 'Infant weight', 'timeFrame': 'postpartum 3 months, 6 months, and 12-months', 'description': "Infants' body weight in gram will be measured by trained data collectors using an electronic scale specifically for infants"}, {'measure': 'Infant height', 'timeFrame': 'postpartum 3 months, 6 months, and 12-months', 'description': "Infants' height in cm will be measured by trained data collectors using an electronic scale specifically for infants"}, {'measure': 'Infant development', 'timeFrame': 'postpartum 3 months, 6 months, and 12-months', 'description': "Infant's social and emotional development will be assessed using the Taiwanese version of the Ages \\& Stages Questionnaires: Social-Emotional-2 (ASQ: SE-2)."}, {'measure': 'Infant feeding', 'timeFrame': 'postpartum 1 month, 3 months, and 6 months, and 12 months', 'description': 'Infant feeding methods will be measured using a self-report questionnaire. The feeding methods, including initiated breastfeeding within 24 hours after birth, and type of breastfeeding.'}, {'measure': 'Satisfaction of sleep intervention', 'timeFrame': 'immediately after interventions', 'description': 'A structured questionnaire with a 5-point Likert scale will be used to collect the level of satisfaction of the sleep intervention upon completion of programs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep quality', 'perinatal', 'depression', 'anxiety', 'infant sleep', 'infant health'], 'conditions': ['Sleep', 'Psychological Distress', 'Perinatal Problems']}, 'descriptionModule': {'briefSummary': 'Background: Sleep disruptions and disturbances are highly prevalent among new mothers and fathers and negatively affect their mental health and infant development outcomes. Effective sleep interventions are vital for family health.\n\nObjectives: To develop a sleep intervention for mother-father-infant triads, and to evaluate the effects on sleep improvement, emotional distress, and infant health outcomes.\n\nMethods: In this proposal, we plan to conduct a parallel-group two-arm randomized controlled trial on pregnant women and their partners. Mother-father-infant triads will be recruited and randomly allocated to the intervention group (receiving a sleep intervention) or the control group. Data will be collected with repeated measures, and the relationship between studied variables will be analyzed with descriptive and inferential statistics.\n\nAnticipatory results: The development and evaluation of an evidence-based sleep intervention will provide a scientific insight into sleep care for pregnant women and their families.', 'detailedDescription': "The primary outcome is the severity of insomnia symptoms. The secondary outcomes of parents' sleep quality, objective sleep indicators, symptoms of depression and anxiety, and heart rate variability will be collected. Infant sleep quality, infant feeding, and infant health outcomes will also be assessed. Data will be analyzed using descriptive and inferential statistics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. First-time mothers and their partners aged 20 and older;\n2. Currently 30 weeks gestation or more, singleton;\n3. insomnia severity index score greater than 10;\n4. living with a husband or partner;\n5. Both women and their partners are willing to participate in and adhere to the research protocol;\n6. be able to read and speak the Mandarin language\n\nExclusion Criteria:\n\n1. sleep disorders, depression or anxiety disorders;\n2. medical diseases with abnormal heart rate variability, or arrhythmia;\n3. taking medicines that may affect the autonomic nervous system or\n4. night shift workers;\n5. obstetric complications, including gestational hypertension, preterm labor, labor complications, or postpartum complications;\n6. infants with fetal deformity, or neonatal complications;\n7. no access to Internet resources'}, 'identificationModule': {'nctId': 'NCT06487650', 'briefTitle': 'The Development and Evaluation of Sleep Intervention for Perinatal Family', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'The Development and Evaluation of Sleep Intervention for Perinatal Family', 'orgStudyIdInfo': {'id': 'N202204079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sleep intervention', 'description': 'Participants in the intervention group will receive both the standardized usual care and the sleep intervention. The intervention consists of sleep education, health professional support, and counseling. The intervention will be delivered from pregnancy to postpartum for mothers and fathers.', 'interventionNames': ['Behavioral: sleep intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants in the control group will receive a perinatal health booklet in addition to the standardized usual care.', 'interventionNames': ['Behavioral: Control group']}], 'interventions': [{'name': 'sleep intervention', 'type': 'BEHAVIORAL', 'description': 'At the beginning of the intervention, participants will have an orientation and overview of the program. Then, participants will follow the curriculum of modules, and professional feedback to complete the intervention.', 'armGroupLabels': ['sleep intervention']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Participants in control group will follow standardized usual care and a perinatal health booklet', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shu-Yu Kuo', 'role': 'CONTACT', 'email': 'sykuo@tmu.edu.tw', 'phone': '+886-2-2736-1661', 'phoneExt': '6301'}], 'overallOfficials': [{'name': 'Shu-Yu Kuo, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}