Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT05078112
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2021-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Sleep Device Testing to Promote Sleep in Infants
Sponsor:
Organization:
Raw JSON
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The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.89', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.000393', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 5 days post-intervention', 'description': 'Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention.', 'unitOfMeasure': 'awakenings per night', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': "The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers were not considered enrolled, but did contribute to this assessment. Each caregiver that had pre and post-intervention BISQ-SF scores available contributed to this assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Caregiver Epworth Sleepiness Scale (ESS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '2.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': 'Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention ESS scores available contributed to this assessment.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire-2 (PHQ-2) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': 'A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers were not considered enrolled but did contribute to this assessment. Each caregiver that had pre and post-intervention PHQ-2 scores available contributed to this assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the Duke Pediatric outpatient clinics from October 2021 to June 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sleep Device Intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days.\n\nInfants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '2.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-28', 'size': 222187, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-24T11:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2021-10-04', 'resultsFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2021-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-25', 'studyFirstPostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary', 'timeFrame': 'Baseline to 5 days post-intervention', 'description': 'Parents reported number of nighttime awakenings on the 5 days immediately prior to intervention (at baseline) and 5 days immediately following the intervention. The intervention takes place during the 20 days in between the measurement of baseline measures and post-intervention measures. The number of nighttime awakenings is averaged over the 5 days prior to intervention and compared to the average over 5 days after intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': "The BISQ-SF is a research tool that measures infant sleep metrics, parental perceptions of the child's sleep, and parental behaviors. The total score is scaled from 0 to 100, with higher scores denoting better sleep quality, more positive perception of infant sleep, and parent behaviors that promote healthy and independent sleep."}, {'measure': 'Change in Caregiver Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': 'Caregivers evaluate their own sleepiness via the ESS. The ESS has a total score range of 0 to 24, where a higher score indicates greater sleepiness.'}, {'measure': 'Change in Patient Health Questionnaire-2 (PHQ-2) Score', 'timeFrame': 'Baseline to post-intervention (approximately 20 days)', 'description': 'A PHQ-2 score ranges from 0 to 6, where a higher score indicates a greater frequency of depressed mood and anhedonia.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Insomnia Chronic']}, 'descriptionModule': {'briefSummary': 'Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 2-12 months.\n2. Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.\n\nExclusion Criteria:\n\n1. Diagnosed comorbid health problem that may disrupt sleep.\n2. History of birth prior to 37 weeks gestational age.'}, 'identificationModule': {'nctId': 'NCT05078112', 'briefTitle': 'Sleep Device Testing to Promote Sleep in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Clinical Testing of a Novel Device to Promote Sleep Continuity in Infants', 'orgStudyIdInfo': {'id': 'Pro00103800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Device intervention', 'description': 'Infants will utilize the sleep device during sleep for 20 days', 'interventionNames': ['Device: Sleep sensor technology']}], 'interventions': [{'name': 'Sleep sensor technology', 'type': 'DEVICE', 'description': 'Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output to soothe them to sleep. The device will give this output for first 10 nights, then wean the output the child receives over 10 nights.', 'armGroupLabels': ['Sleep Device intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sujay Kansagra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}