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

Completed

• Conditions: Cystic Fibrosis; Sleep Disorder
• Interventions: Behavioral: Questionnaire

• Registration Number: NCT04847882
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Study Start: 2021-05-20
• Primary Completion: 2021-08-09
• Study Completion: 2021-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cystic fibrosis, children from 6 to 17.	Questionnaire	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.
Control group, children from 6 to 17.	Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Questionnaire SDSC	15 minutes	The specific measure for our first purpose is a validated questionnaire called SDSC for "Sleep Disturbance Scale for Children"

Secondary Outcome Measures

Name	Time	Method
Questionnaire SDSC	15 minutes	Questions about sleep and life hygiene, various pathologies to highlight modifiable non-respiratory factors of sleep disorders

Trial Locations

Locations (1)

Hôpitaux Universitaire de Strasbourg; 🇫🇷 Strasbourg, France