Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-13 @ 7:16 PM
Study NCT ID:
NCT01739712
Status:
COMPLETED
Last Update Posted:
2016-11-21
First Post:
2012-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Intervention for Youth With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-17', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2012-11-29', 'lastUpdatePostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Academic Rating Scale', 'timeFrame': '2 weeks', 'description': 'A teacher behavioral rating of classroom behaviors and performance'}, {'measure': 'Glucose control', 'timeFrame': '2 weeks', 'description': 'Continuous glucose monitor'}, {'measure': 'Neurocognitive performance', 'timeFrame': '2 weeks', 'description': 'Cogstate learning and memory tasks'}, {'measure': 'Academic performance', 'timeFrame': '2 weeks', 'description': 'Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Sleep problems', 'School', 'Neurobehavioral'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'Sleep intervention for youth with diabetes', 'detailedDescription': "It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of type 1 diabetes\n* enrolled in school\n\nExclusion Criteria:\n\n* not hospitalized within past month\n* neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation'}, 'identificationModule': {'nctId': 'NCT01739712', 'briefTitle': 'Sleep Intervention for Youth With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement', 'orgStudyIdInfo': {'id': '12-0733091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleep Extension', 'description': 'All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer', 'interventionNames': ['Behavioral: Sleep extension']}, {'type': 'SHAM_COMPARATOR', 'label': 'Fixed Sleep Duration', 'description': 'All youth in this condition are asked to maintain their baseline sleep duration.', 'interventionNames': ['Behavioral: Fixed Sleep Duration']}], 'interventions': [{'name': 'Sleep extension', 'type': 'BEHAVIORAL', 'description': 'There will be a consultation with families to help youth to be successful in extending their sleep.', 'armGroupLabels': ['Sleep Extension']}, {'name': 'Fixed Sleep Duration', 'type': 'BEHAVIORAL', 'description': 'There will be a consultation with families to instruct youth to maintain the same average nightly sleep duration during the modification week. The purpose is to control for time and attention.', 'armGroupLabels': ['Fixed Sleep Duration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Angel Wing Clinic for Diabetes', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Michelle M Perfect, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UA College of Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michelle Perfect', 'investigatorAffiliation': 'University of Arizona'}}}}