Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Connected tools.
- Who it may be relevant to
- Registry conditions: Sleep Disorders. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Overview
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.
Interventions
- 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.
Primary outcome measures
- Sensitivity of the diagnosis of sleep disorder [Time frame: 15 days]
- Specificity of the diagnosis of sleep disorder [Time frame: 15 days]
Secondary outcome measures (5)
- Diagnosis [Time frame: 15 days]
- Acceptability assessed by acceptability score for parents, and if possible children [Time frame: 15 days]
- Sleep Quality Questionnaire [Time frame: 15 days]
- Data quality outcome measures [Time frame: 25 months]
- A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life [Time frame: 25 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 6 centers
- CHU Angers — Angers
- CHRU Brest — Brest
- Fondation Ildys Ty-Yann — Brest
- ESEAN Nantes — Nantes
- AP-HP Hôpital Trousseau — Paris
- Kerpape — Ploemeur
Identifiers
NCT: NCT03915418 · SOUTIEN-PC (29BRC18.0178)