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

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.

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Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Questionnaire SDSC

Time frame: 15 minutes

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

Secondary outcomes

Questionnaire SDSC

Time frame: 15 minutes

Questions about sleep and life hygiene, various pathologies to highlight modifiable non-respiratory factors of sleep disorders

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Apr 19, 2021
Registry last updated: Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed