Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-28 @ 5:33 AM
Study NCT ID:
NCT02676492
Status:
COMPLETED
Last Update Posted:
2017-08-22
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013981', 'term': 'Tic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004526', 'term': 'Efficiency'}], 'ancestors': [{'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-17', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-02-03', 'lastUpdatePostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between sleep efficiency/duration and cognitive learning', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Cognitive functioning', 'timeFrame': 'Within the 14 days of the study', 'description': 'A range of cognitive measures will be used to assess general level of intellectual functioning and cognitive skills that are hypothesised to contribute to performance on the SleepSuite learning tasks (including memory, attention, visuo-motor co-ordination and phonological awareness).'}, {'measure': 'Mood and behavioural functioning', 'timeFrame': 'Within the 14 days of the study', 'description': "A range of self- and parent-report questionnaires will be used to measure participants' mood and behaviour and to see whether these relate to the primary outcome measures of sleep and cognitive learning."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tic Disorders']}, 'descriptionModule': {'briefSummary': 'This study will explore the relationship between sleep, learning, cognition, mood and behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder) compared to typically developing peers.', 'detailedDescription': "This project explores the relationship between sleep and learning in childhood with tic disorders, such as Tourette syndrome (TS) and chronic tic disorders (CTD).\n\nTS/CTD are movement disorders characterized by repetitive involuntary movements and/or vocalizations called tics. Sleep related problems are commonly reported for children with TS/CTD and may include problems getting to sleep, waking up frequently during the night, early wakening and tic-related movements in sleep. For typically developing children, sleep disturbances have been linked to problems with mood, behaviour and learning. To date, the relationship between sleep and learning has not been explored for children with TS/CTD.\n\nThe aim of this project is to investigate whether there is a relationship between sleep efficiency and learning in boys with and without TS/CTD aged 11-14 years.\n\nSleep efficiency will be measured using a small actigraphy watch, which will collect information about movements during sleep, night time waking and light exposure. Children will be required to wear the watch for 14 days and nights. Before one night of sleep and again the next morning, children will be asked to complete some tasks on an iPad Air to assess learning. These include 1) 'popping' balloons with faces on them according to specific rules (e.g. boys faces, happy faces), 2) learning novel animal names, 3) navigating a 3D maze. Children will also be administered some standard tests to look at level of intellectual functioning, memory and other thinking skills that may contribute to performance on the computerized tasks. Additionally, children and their parents will be asked to complete questionnaires to assess tics, quality of life, mood and behaviour. The findings of this study will help improve understanding of sleep problems for children with tic disorders to aid the development of specific interventions for this group."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Students at mainsteam secondary schools, patients of the Tic and Neurodevelopmental (TANDeM) service at the Evelina Children's Hospital.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Tourette Syndrome or Chronic Tic Disorder (for clinical group)\n\nExclusion Criteria:\n\n* Diagnosis of Intellectual Disability (i.e. Full Scale IQ (IntellIigence Quotient) below 70), Autism Spectrum Disorder or Depression\n* Currently taking medications to support tic, mood and/or behaviour management'}, 'identificationModule': {'nctId': 'NCT02676492', 'briefTitle': 'A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders', 'orgStudyIdInfo': {'id': 'HR-15/16-2278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tic Disorder', 'description': 'Boys with a diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD) aged 11-14 years', 'interventionNames': ['Other: Actigraphy to measure sleep duration and efficiency', "Other: 'Sleepsuite' novel cognitive learning tasks"]}, {'label': 'Control', 'description': 'Boys aged 11-14 years without a diagnosis of TS/CTD (i.e. typically developing)', 'interventionNames': ['Other: Actigraphy to measure sleep duration and efficiency', "Other: 'Sleepsuite' novel cognitive learning tasks"]}], 'interventions': [{'name': 'Actigraphy to measure sleep duration and efficiency', 'type': 'OTHER', 'description': "Actigraphy watch to be worn on participants' wrist for 14 days and nights", 'armGroupLabels': ['Control', 'Tic Disorder']}, {'name': "'Sleepsuite' novel cognitive learning tasks", 'type': 'OTHER', 'description': 'Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.', 'armGroupLabels': ['Control', 'Tic Disorder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': "Evelina Children's Hospital, St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Sally Robinson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}