NCT02676492

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

February 3, 2016

Last Update Submit

August 17, 2017

Conditions

Tic Disorders

Outcome Measures

Primary Outcomes (1)

  • Relationship between sleep efficiency/duration and cognitive learning

    14 days

Secondary Outcomes (2)

  • Cognitive functioning

    Within the 14 days of the study

  • Mood and behavioural functioning

    Within the 14 days of the study

Study Arms (2)

Tic Disorder

Boys with a diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD) aged 11-14 years

Other: Actigraphy to measure sleep duration and efficiencyOther: 'Sleepsuite' novel cognitive learning tasks

Control

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

Other: Actigraphy to measure sleep duration and efficiencyOther: 'Sleepsuite' novel cognitive learning tasks

Interventions

Actigraphy to measure sleep duration and efficiencyOTHER

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

ControlTic Disorder
'Sleepsuite' novel cognitive learning tasksOTHER

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

ControlTic Disorder

Eligibility Criteria

Age11 Years - 14 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Diagnosis of Tourette Syndrome or Chronic Tic Disorder (for clinical group)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evelina Children's Hospital, St Thomas' Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Tic Disorders

Interventions

Efficiency

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Organization and AdministrationHealth Services Administration

Study Officials

  • Sally Robinson

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 8, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 22, 2017

Record last verified: 2016-08

Locations

GB(1)