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

NCT04847882 | Completed

• 1 other identifier: 8228
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Children; Case control study

Outcome Measures

Primary Outcomes (1)

• Questionnaire SDSC

  The specific measure for our first purpose is a validated questionnaire called SDSC for "Sleep Disturbance Scale for Children"

  15 minutes

Secondary Outcomes (1)

• Questionnaire SDSC

  15 minutes

Study Arms (2)

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

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

Interventions

Questionnaire 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.; Cystic fibrosis, children from 6 to 17.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Cystic Fibrosis; Sleep Wake Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: May 20, 2021
• Primary Completion: August 9, 2021
• Study Completion: December 20, 2021
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

FR (1)