Case-control Study of Sleep Disorders in Children With Cystic Fibrosis
Sleep Disorders in Patients Aged From 6 to 17 With Cystic Fibrosis: a Single-center Case-control Study at Strasbourg University Hospital
Our primary purpose is to compare the prevalence of sleep disorders in children aged 6 to 17 with cystic fibrosis versus controls with a Sleep disorder screening score, the SDSC. Our hypothesis is that patients aged 6 to 17 with cystic fibrosis have a higher prevalence of sleep disturbances than the general population of the same age group.
Our secondary hypothesis is that these sleep disorders are mixed and that there are non-respiratory causes, sometimes modifiable by simple non-medical treatment and that's why our secondary purpose is to identify the responsible factors, in particular non-respiratory factors in the 2 groups and to compare them.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Strasbourg, France, 67091
- Hopitaux Universitaire de Strasbourg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria for the case group :
- Cystic fibrosis followed at the pediatric (Centre de Ressources et de Compétences de la Mucoviscidose) in Strasbourg
- Aged from 6 to 17 years old
- Non hospitalized
- Able to read and understand French language
- Accompanied by at least one of his parents
Inclusion criteria for the control group :
- Emergency surgical consultation
- Aged from 6 to 17 years old
- Non hospitalized
- Able to read and understand French langage
- Accompanied by at least one of his parents
Exclusion criteria:
- Children under 6 years old
- Children over 17 years old
- Children and parents who don't understand or can't read French language
- Hospitalized children
- Children unaccompanied by their parents
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cystic fibrosis, children from 6 to 17.
This group is made up of children with cystic fibrosis followed at the Strasbourg pediatrics CRCM, aged from 6 to 17 years old, not hospitalized at the time of inclusion, without any other criterion prejudging the seriousness of the pathology.
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Questionnaire submitted to the parents of children with cystic fibrosis aged 6 to 17 years and to controls in order to assess and compare the prevalence of sleep disorders and their main non-respiratory causes
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Control group, children from 6 to 17.
This group is the control group. It is made up of children consulting in pediatric surgical emergencies, aged 6 to 17 years. Surgical emergencies were chosen because it is a point of consultation, rather accidental, where sleep has often not been impacted in the previous months and where the frequency of chronic pathology is not higher than the general population. An other criteria is that these children are accompanied by at least one of their parents and that they can read and understand French well. |
Questionnaire submitted to the parents of children with cystic fibrosis aged 6 to 17 years and to controls in order to assess and compare the prevalence of sleep disorders and their main non-respiratory causes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire SDSC
Time Frame: 15 minutes
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The specific measure for our first purpose is a validated questionnaire called SDSC for "Sleep Disturbance Scale for Children"
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire SDSC
Time Frame: 15 minutes
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Questions about sleep and life hygiene, various pathologies to highlight modifiable non-respiratory factors of sleep disorders
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15 minutes
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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