Clinical trial NCT02676492: A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
Official title: A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tic Disorders
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2016-02-08
Enrollment: 32
Sex: MALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between sleep efficiency/duration and cognitive learning
timeFrame: 14 days
Secondary outcomes:
measure: Cognitive functioning
timeFrame: Within the 14 days of the study
measure: Mood and behavioural functioning
timeFrame: Within the 14 days of the study
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Evelina Children's Hospital, St Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Sally Robinson
role: PRINCIPAL_INVESTIGATOR
References: