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: Completed
• Conditions: Sleep Disorder; Cystic Fibrosis
• Intervention / Treatment: Behavioral: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hopitaux Universitaire de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children from 6 to 17 years with cystic fibrosis for the case group and children with an emergency surgical consultation for the control group

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire SDSC	The specific measure for our first purpose is a validated questionnaire called SDSC for "Sleep Disturbance Scale for Children"	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire SDSC	Questions about sleep and life hygiene, various pathologies to highlight modifiable non-respiratory factors of sleep disorders	15 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): August 9, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Children; Case control study
• Additional Relevant MeSH Terms: Mental Disorders; Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Neurologic Manifestations; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Sleep Wake Disorders; Parasomnias; Cystic Fibrosis
• Other Study ID Numbers: 8228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No