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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

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