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

Tic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676492
• Other study ID #: HR-15/16-2278
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: August 17, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2016
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Tic Disorders
• Tics

Intervention

Other:
• Actigraphy to measure sleep duration and efficiency
Actigraphy watch to be worn on participants' wrist for 14 days and nights
• 'Sleepsuite' novel cognitive learning tasks
Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.

Locations

Country	Name	City	State
United Kingdom	Evelina Children's Hospital, St Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between sleep efficiency/duration and cognitive learning		14 days
Secondary	Cognitive functioning	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
Secondary	Mood and behavioural functioning	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