Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools (SOUTIEN-PC)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Sleep Disorders

Treatments: Procedure: Connected tools

Study type: Interventional

Funder types: Other

Identifiers

NCT03915418

SOUTIEN-PC (29BRC18.0178)

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Connected tools

Experimental group

Description:

1 night at home with connected tools only and 1 night at hospital with connected tools and PSG.

Treatment:

Procedure: Connected tools