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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Connected tools

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

Group Type EXPERIMENTAL

Connected tools

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliette Ropars, MD

Role: PRINCIPAL_INVESTIGATOR

Brest University Hospital in France

Locations

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