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Completed

NCT Number: NCT02676492

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

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.

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Key information

Conditions

Tic Disorders Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodevelopmental Disorders

Age range

11 year–14 year

Sex eligibility

Male

Study type

Observational

Primary location

Evelina Children's Hospital, St Thomas' Hospital

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actigraphy to measure sleep duration and efficiency

Other

Actigraphy watch to be worn on participants' wrist for 14 days and nights

'Sleepsuite' novel cognitive learning tasks

Other

Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.

Primary outcomes

  1. Relationship between sleep efficiency/duration and cognitive learning

    Time frame: 14 days

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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