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

Primary Purpose

Sleep Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Connected tools
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Disorders focused on measuring Screening, sleep disorders, children, cerebral palsy, connected tools

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CHU Angers
  • CHRU BrestRecruiting
  • Fondation Ildys Ty-Yann
  • ESEAN Nantes
  • AP-HP Hôpital Trousseau
  • Kerpape

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Connected tools

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Diagnosis
Sensitivity and specificity of sleep disorder diagnosis using tools connected during 1 night at home (in comparaison with sleep disorder diagnosis using PSG)
Acceptability assessed by acceptability score for parents, and if possible children
Acceptability assessed by the acceptability score for parents, and if possible children, obtained by the SUS "System Usability Scale" scale. This questionnaire consists of ten questions to collect the subjective point of view of the user on the systems used
Sleep Quality Questionnaire
Sleep quality questionnaire used as a screening tool for sleep disorders: use of the Sleep Disturbance Scale for Children. Sleep Disturbance Scale for Children (SDSC) is a screening tool for sleep disorders in children and adolescents with good psychometric properties. It is one of the most used sleep questionnaires in the clinic but also in clinical research. Since its creation, the SDSC has been translated into several languages and recently validated in French. The ranking is obtained from a 26-item questionnaire completed by the parents. This scale distinguishes 6 major groups of sleep disorders: disorders of the installation or maintenance of sleep, breathing disorders, waking disorders, sleep-wake transition disorders, excessive daytime sleepiness and hypersudation of sleep.
Data quality outcome measures
Data quality will be assessed by establishing for each sensor the ratio (expressed in percent value) between the duration of the data effectively recorded to the total duration the patient weared the sensors. Pauses in recording during recording sessions will be identified in absolute value and duration for each sensor. Specific issues in recording will be reported, especially regarding the contents of RAW files.
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life, measured as quality-adjusted life year QALY, will be simulated for one-year health conditions.

Full Information

First Posted
December 7, 2018
Last Updated
May 15, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT03915418
Brief Title
Validation of a Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Acronym
SOUTIEN-PC
Official Title
Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders
Keywords
Screening, sleep disorders, children, cerebral palsy, connected tools

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Connected tools
Arm Type
Experimental
Arm Description
1 night at home with connected tools only and 1 night at hospital with connected tools and PSG.
Intervention Type
Procedure
Intervention Name(s)
Connected tools
Intervention Description
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 Measure Information:
Title
Sensitivity of the diagnosis of sleep disorder
Description
Sensitivity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Time Frame
15 days
Title
Specificity of the diagnosis of sleep disorder
Description
Specificity of sleep disorder diagnosis (positive / negative) obtained using connected tools in reference to that obtained by PSG
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Diagnosis
Description
Sensitivity and specificity of sleep disorder diagnosis using tools connected during 1 night at home (in comparaison with sleep disorder diagnosis using PSG)
Time Frame
15 days
Title
Acceptability assessed by acceptability score for parents, and if possible children
Description
Acceptability assessed by the acceptability score for parents, and if possible children, obtained by the SUS "System Usability Scale" scale. This questionnaire consists of ten questions to collect the subjective point of view of the user on the systems used
Time Frame
15 days
Title
Sleep Quality Questionnaire
Description
Sleep quality questionnaire used as a screening tool for sleep disorders: use of the Sleep Disturbance Scale for Children. Sleep Disturbance Scale for Children (SDSC) is a screening tool for sleep disorders in children and adolescents with good psychometric properties. It is one of the most used sleep questionnaires in the clinic but also in clinical research. Since its creation, the SDSC has been translated into several languages and recently validated in French. The ranking is obtained from a 26-item questionnaire completed by the parents. This scale distinguishes 6 major groups of sleep disorders: disorders of the installation or maintenance of sleep, breathing disorders, waking disorders, sleep-wake transition disorders, excessive daytime sleepiness and hypersudation of sleep.
Time Frame
15 days
Title
Data quality outcome measures
Description
Data quality will be assessed by establishing for each sensor the ratio (expressed in percent value) between the duration of the data effectively recorded to the total duration the patient weared the sensors. Pauses in recording during recording sessions will be identified in absolute value and duration for each sensor. Specific issues in recording will be reported, especially regarding the contents of RAW files.
Time Frame
25 months
Title
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life
Description
A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life, measured as quality-adjusted life year QALY, will be simulated for one-year health conditions.
Time Frame
25 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette Ropars, MD
Phone
02 98 22 33 89
Ext
+33
Email
juliette.ropars@chu-brest.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette Ropars, MD
Organizational Affiliation
Brest University Hospital in France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael Dinomais, Professor
Email
mickael.dinomais@gmail.com
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette Ropars, MD
Email
juliette.ropars@chu-brest.fr
Facility Name
Fondation Ildys Ty-Yann
City
Brest
ZIP/Postal Code
29218
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Barzic, MD
Email
audrey.bazic@ildys.org
Facility Name
ESEAN Nantes
City
Nantes
ZIP/Postal Code
44200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Letellier, MD
Facility Name
AP-HP Hôpital Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Aubertin, MD
Email
guillaume.aubertin@aphp.fr
Facility Name
Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Bernier-François, MD
Email
vbernier-francois@kerpape.mutualite56.fr

12. IPD Sharing Statement

Learn more about this trial

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

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