Characterising Sleep Disorders in Children With Tourette Syndrome
ConditionTourette Syndrome
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorSteffi Baker
About this trial
Healthy sleep is essential for a young person's growth, development, and wellbeing. It is estimated that up to 80% of young people with Tourette Syndrome experience sleep difficulties. Tourette Syndrome is a neurological condition that causes sudden, unwanted, and repeated motor movements and vocal sounds, known as tics. Previous studies have shown that children with this condition have poorer sleep quality, specifically increased awakenings and difficulties falling or staying asleep. These challenges highlight the need to better understand sleep problems in young people with Tourette Syndrome.
This study will assess whether children's tics affect their sleep quality by measuring how often tics occur during sleep and how severe they are. To do this, the investigators will use a new Tic index to measure the impact of tics during an overnight sleep study. A watch like device that tracks movement and light levels will also be employed to help estimate when someone is asleep or awake. Together, these measures enable a clear comparison between the sleep of children with Tourette Syndrome and those without. Children will also complete a questionnaire to gain insights into their personal experiences and how they perceive tics to influence their sleep.
The specific objectives include:
1. Compare the sleep patterns of children with Tourette syndrome (TS) to those of children without TS, to see whether tics are linked to any differences in sleep. 2. Assess how accurately the tic measurements identify tics during sleep, to see whether they could be useful in future research. 3. Explore whether tic activity changes during different stages of sleep in children with TS. 4. Look at how the results from sleep recordings (such as movement monitors and tic measurements) relate to questionnaire responses about sleep and tics.
Results from this study can be used to support future research that continues to improve the management and treatment of sleep problems in Tourette Syndrome children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients already under investigation by Evelina London Children's Hospital for sleep disturbances
Diagnosis of Tourette Syndrome in accordance with the International Classification of Diseases (ICD-10;F95.2)
Ages 6-17 at time of recruitment, and not between transition or due to transition to adult services
Have had a successful and compliant PSG, ideally within 6 months of recruitment
Disqualifiers
Any physician diagnosed chronic medical condition that could impact their study participation
Non-verbal participants without access to appropriate communication support
Non-English-speaking participants without access to appropriate translator
Trial population
Participants will be between the ages of 6-17. All participants will have been referred to the sleep service team, known by the Tics and neuro-developmental movements (TandDEM) team, and will meet the diagnostic criteria for TS according to the International Classification of Diseases (ICD-10; F95.2).
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
34 Participants
are grouped into 2 trial groupsGroup A: Children with Tourette Syndrome - QOG
Group B: Children with Tourette Syndrome - SSQG
Trial outcomes
Primary outcomes
1
Tic index as a measure of sleep quality.
Tics in sleep (Ts) and tics in sleep that cause arousals (Tsa) will be combined to produce a Tic Index. The Tic index will quantify sleep quality in children with Tourette syndrome. Higher scores will indicate greater impact on sleep quality, thus worse sleep.
Time frame
Through study completion, on average18 months.2
Tic in sleep questionnaire scores
Responses from the Tic in sleep questionnaire will be scored accordingly based on the reported impact on sleep. Higher scores will indicate greater impact on sleep quality, thus worse sleep.
Time frame
From receipt of 34 questionnaire responses to study completion, on average 12months.Secondary outcomes
1
Apnoea-hypopnoea index (AHI) from PSG
The AHI will be compared in PSG results from children with Tourette Syndrome and data from age-matched historical controls. Higher score indicates worse sleep.
Time frame
Through study completion, on average 18months.2
Total Sleep Time (TST) from PSG
The TST will be compared in PSG results from children with Tourette Syndrome and data from age-matched historical controls. Lower score typically indicates worse sleep.
Time frame
Through study completion, on average18 months3
Sleep Efficiency from PSG
Sleep efficiency will be compared in PSG results from children with Tourette Syndrome and data from age-matched historical controls. Lower score indicates worse sleep.
Time frame
Through study completion, on average18 months.4
Sleep Latency from PSG
The sleep latenccy will be compared in PSG results from children with Tourette Syndrome and data from age-matched historical controls. Higher score indicates worse sleep.
Time frame
Through study completion, on average18 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Steffi Baker
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Sponsor institution
Guy's and St Thomas' NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: