Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

Sleep Disorders Clinical Trial

— SOUTIEN-PC  

Official title:

Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915418
• Other study ID #: SOUTIEN-PC (29BRC18.0178)
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: February 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Brest
• Contact: Juliette Ropars, MD
• Phone: 02 98 22 33 89
• Email: juliette.ropars[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cerebral palsy (CP) is the most common cause of child disability. Nearly 40% of PC children suffer from sleep disorders, which are not routinely screened. The neuro-cognitive, physical and environmental morbidity of sleep disorders should require their diagnosis and management. Limited access to the reference exam (polysomnography or PSG) delays the diagnosis and only allows screening of these disorders for a limited number of PC children. The hypothesis of our study is that connected technologies could optimize screening for sleep disorders in PC children by selecting children requiring PSG exploration and specific management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• Boy or girl between 6 and 15 years old
• Confirmed diagnosis of cerebral palsy
• GMFCS class> 3
• Parents and child agreement

Exclusion Criteria:

• Pharmacological treatment of sleep disorders
• Diurnal and / or nocturnal ventilatory support
• Difficulty understanding and / or participation
• Subjects under 6 and over 15
• Refusal to participate
• Not affiliated with and not a beneficiary of a health insurance plan

Related Conditions & MeSH terms

• Cerebral Palsy
• Disease
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Procedure:
• Connected tools
At home, parents will record their child's sleep for 1night Then, on the date scheduled for the inclusion of the children and after the recording of the 1 night at home, the child will spend a night in a hospital environment to carry out the recording by polysomnography and tools connected simultaneously.

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	Fondation Ildys Ty-Yann	Brest
France	ESEAN Nantes	Nantes
France	AP-HP Hôpital Trousseau	Paris
France	Kerpape	Ploemeur

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the diagnosis of sleep disorder	Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG	15 days
Primary	Specificity of the diagnosis of sleep disorder	Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG	15 days
Secondary	Diagnosis	Sensitivity and specificity of sleep disorder diagnosis using tools connected during 1 night at home (in comparaison with sleep disorder diagnosis using PSG)	15 days
Secondary	Acceptability assessed by acceptability score for parents, and if possible children	Acceptability assessed by the acceptability score for parents, and if possible children, obtained by the SUS "System Usability Scale" scale. This questionnaire consists of ten questions to collect the subjective point of view of the user on the systems used	15 days
Secondary	Sleep Quality Questionnaire	Sleep quality questionnaire used as a screening tool for sleep disorders: use of the Sleep Disturbance Scale for Children. Sleep Disturbance Scale for Children (SDSC) is a screening tool for sleep disorders in children and adolescents with good psychometric properties. It is one of the most used sleep questionnaires in the clinic but also in clinical research. Since its creation, the SDSC has been translated into several languages and recently validated in French. The ranking is obtained from a 26-item questionnaire completed by the parents. This scale distinguishes 6 major groups of sleep disorders: disorders of the installation or maintenance of sleep, breathing disorders, waking disorders, sleep-wake transition disorders, excessive daytime sleepiness and hypersudation of sleep.	15 days
Secondary	Data quality outcome measures	Data quality will be assessed by establishing for each sensor the ratio (expressed in percent value) between the duration of the data effectively recorded to the total duration the patient weared the sensors. Pauses in recording during recording sessions will be identified in absolute value and duration for each sensor. Specific issues in recording will be reported, especially regarding the contents of RAW files.	25 months
Secondary	A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life	A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life, measured as quality-adjusted life year QALY, will be simulated for one-year health conditions.	25 months