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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04847882

Enrollment

150

Registered

2021-04-19

Start date

2021-05-20

Completion date

2021-12-20

Last updated

2023-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Sleep Disorder

Keywords

Children, Case control study

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.

Interventions

BEHAVIORALQuestionnaire

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026