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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Boy or girl between 6 and 15 years old

Confirmed diagnosis of cerebral palsy

GMFCS class> 3

Parents and child agreement

Disqualifiers

Pharmacological treatment of sleep disorders

Diurnal and / or nocturnal ventilatory support

Difficulty understanding and / or participation

Subjects under 6 and over 15

Trial design

Design model

Single group

Treatments tested in this trial

  • Connected tools

    Procedure/Surgery

    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.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Connected toolsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
15 days
2

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

Time frame
15 days

Secondary outcomes

1

Diagnosis

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
2

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

Time frame
15 days
3

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.

Time frame
15 days
4

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.

Time frame
25 months

Other outcomes

Sponsors and contacts

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