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NCT04847882 Clinical Trial

Case-control Study of Sleep Disorders in Children With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
Sleep Disorders in Patients Aged From 6 to 17 With Cystic Fibrosis: a Single-center Case-control Study at Strasbourg University Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04847882
Other study ID # 8228
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 20, 2021
Est. completion date December 20, 2021

Study information
Verified date February 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 20, 2021
Est. primary completion date August 9, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Questionnaire
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

Locations
Country Name City State
France Hôpitaux Universitaire de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Questionnaire SDSC The specific measure for our first purpose is a validated questionnaire called SDSC for "Sleep Disturbance Scale for Children" 15 minutes
Secondary Questionnaire SDSC Questions about sleep and life hygiene, various pathologies to highlight modifiable non-respiratory factors of sleep disorders 15 minutes
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