Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Brest
- Enrollment
- 140
- Locations
- 12
- Primary Endpoint
- Specificity of the diagnosis of sleep disorder
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Connected tools
1 night at home with connected tools only and 1 night at hospital with connected tools and PSG.
Intervention: Connected tools (Procedure)
Outcomes
Primary Outcomes
Specificity of the diagnosis of sleep disorder
Time Frame: 15 days
Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Sensitivity of the diagnosis of sleep disorder
Time Frame: 15 days
Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Secondary Outcomes
- A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life(25 months)
- Acceptability assessed by acceptability score for parents, and if possible children(15 days)
- Sleep Quality Questionnaire(15 days)
- Data quality outcome measures(25 months)
- Diagnosis(15 days)