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

NCT ID: NCT04847882

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2021-12-20

Brief 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.

Conditions

Cystic Fibrosis; Sleep Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Questionnaire

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Universitaire de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

8228

Identifier Type: -

Identifier Source: org_study_id