NCT03915418

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 12, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

December 7, 2018

Last Update Submit

February 4, 2025

Conditions

Sleep Disorders

Keywords

Screeningsleep disorderschildrencerebral palsyconnected tools

Outcome Measures

Primary Outcomes (2)

  • 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

    15 days

  • 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

    15 days

Secondary Outcomes (5)

  • Diagnosis

    15 days

  • Acceptability assessed by acceptability score for parents, and if possible children

    15 days

  • Sleep Quality Questionnaire

    15 days

  • Data quality outcome measures

    25 months

  • A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life

    25 months

Study Arms (1)

Connected tools

EXPERIMENTAL

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

Procedure: Connected tools

Interventions

Connected toolsPROCEDURE

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.

Connected tools

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Boy or girl between 6 and 15 years old
  • Confirmed diagnosis of cerebral palsy
  • GMFCS class\> 3
  • Parents and child agreement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Angers

Angers, 49000, France

NOT YET RECRUITING

CHRU Brest

Brest, 29200, France

RECRUITING

Fondation Ildys Ty-Yann

Brest, 29218, France

NOT YET RECRUITING

ESEAN Nantes

Nantes, 44200, France

NOT YET RECRUITING

AP-HP Hôpital Trousseau

Paris, 75012, France

NOT YET RECRUITING

Kerpape

Ploemeur, 56275, France

NOT YET RECRUITING

MeSH Terms

Conditions

Sleep Wake DisordersCerebral Palsy

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Juliette Ropars, MD

    Brest University Hospital in France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliette Ropars, MD

CONTACT

02 98 22 33 89juliette.ropars@chu-brest.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2018

First Posted

April 16, 2019

Study Start

January 12, 2021

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Locations

FR(6)