NCT Number: NCT03915418
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.
Interested in participating?
Request Info6 year–15 year
All sexes
Interventional
Not applicable
CHU Angers, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 15 days
Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Time frame: 15 days
Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Time frame: 15 days
Sensitivity and specificity of sleep disorder diagnosis using tools connected during 1 night at home (in comparaison with sleep disorder diagnosis using PSG)
Time frame: 15 days
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
Time frame: 15 days
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.
Time frame: 25 months
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.
Time frame: 25 months
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.
Contact information is provided by the study sponsor or research team.
University Hospital, Brest
Other
Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Acronym: SOUTIEN-PC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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