A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders

August 17, 2017 updated by: King's College London
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.

Study Overview

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

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom
        • Evelina Children's Hospital, St Thomas' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Students at mainsteam secondary schools, patients of the Tic and Neurodevelopmental (TANDeM) service at the Evelina Children's Hospital.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Control
Boys aged 11-14 years without a diagnosis of TS/CTD (i.e. typically developing)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship between sleep efficiency/duration and cognitive learning
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive functioning
Time Frame: Within the 14 days of the study
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).
Within the 14 days of the study
Mood and behavioural functioning
Time Frame: Within the 14 days of the study
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.
Within the 14 days of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sally Robinson, Guy's and St Thomas' NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2016

More Information

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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