- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02676492
A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
Study Overview
Status
Conditions
Detailed Description
This project explores the relationship between sleep and learning in childhood with tic disorders, such as Tourette syndrome (TS) and chronic tic disorders (CTD).
TS/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.
The 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.
Sleep 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom
- Evelina Children's Hospital, St Thomas' Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Tourette Syndrome or Chronic Tic Disorder (for clinical group)
Exclusion Criteria:
- Diagnosis of Intellectual Disability (i.e. Full Scale IQ (IntellIigence Quotient) below 70), Autism Spectrum Disorder or Depression
- Currently taking medications to support tic, mood and/or behaviour management
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tic Disorder
Boys with a diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD) aged 11-14 years
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Actigraphy watch to be worn on participants' wrist for 14 days and nights
Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.
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Control
Boys aged 11-14 years without a diagnosis of TS/CTD (i.e.
typically developing)
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Actigraphy watch to be worn on participants' wrist for 14 days and nights
Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between sleep efficiency/duration and cognitive learning
Time Frame: 14 days
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14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive functioning
Time Frame: Within the 14 days of the study
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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).
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Within the 14 days of the study
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Mood and behavioural functioning
Time Frame: Within the 14 days of the study
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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.
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Within the 14 days of the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sally Robinson, Guy's and St Thomas' NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-15/16-2278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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