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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915418
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Sleep Disorders Procedure: Connected tools Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Simple Method of Screening for Sleep Disorders in Children With Cerebral Palsy, Using Connected Tools
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Connected tools
3 nights at home with connected tools only and 1 night at hospital with connected tools and PSG.
Procedure: Connected tools
At home, parents will record their child's sleep for 3 consecutive nights Then, on the date scheduled for the inclusion of the children and after the recording of the 3 nights 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 Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Diagnosis [ Time Frame: 15 days ]
    Sensitivity and specificity of sleep disorder diagnosis using tools connected during 3 night at home (in comparaison with sleep disorder diagnosis using PSG)

  2. Acceptability assessed by acceptability score for parents, and if possible children [ Time Frame: 15 days ]
    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

  3. Sleep Quality Questionnaire [ Time Frame: 15 days ]
    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.

  4. Data quality outcome measures [ Time Frame: 25 months ]
    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.

  5. A cost analysis of the sensor screening strategy will be compared to the PSG and the quality of life [ Time Frame: 25 months ]
    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.



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • PSG's history of sleep analysis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915418


Contacts
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Contact: Juliette Ropars, MD 02 98 22 33 89 ext +33 juliette.ropars@chu-brest.fr

Locations
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France
CHU Angers
Angers, France, 49000
Contact: Mickael Dinomais, Professor       mickael.dinomais@gmail.com   
CHRU Brest
Brest, France, 29200
Contact: Juliette Ropars, MD       juliette.ropars@chu-brest.fr   
Fondation Ildys Ty-Yann
Brest, France, 29218
Contact: Audrey Barzic, MD       audrey.bazic@ildys.org   
ESEAN Nantes
Nantes, France, 44200
Contact: Guy Letellier, MD         
AP-HP Hôpital Trousseau
Paris, France, 75012
Contact: Guillaume Aubertin, MD       guillaume.aubertin@aphp.fr   
Kerpape
Ploemeur, France, 56275
Contact: Véronique Bernier-François, MD       vbernier-francois@kerpape.mutualite56.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Juliette Ropars, MD Brest University Hospital in France
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03915418    
Other Study ID Numbers: SOUTIEN-PC (29BRC18.0178)
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Brest:
Screening
sleep disorders
children
cerebral palsy
connected tools
Additional relevant MeSH terms:
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Cerebral Palsy
Sleep Wake Disorders
Parasomnias
Disease
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Mental Disorders