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Study identifier: NCT06370962 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators

Condition: Cystic Fibrosis  ·  Sponsor: Hospices Civils de Lyon

PhaseN/A
Planned participants180
Who can joinAll sexes, 2 Years to 17 Years
Healthy volunteersNo

About this study

Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life. Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening. The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbα could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances. In the era of highly e…

This description comes directly from the study's public registry record.

Talk to the study team

Laurianne COUTIER, MD  ·  04 27 85 50 42  ·  laurianne.coutie@chu-lyon.fr

Catherine CHEN, MD  ·  04 27 85 50 42  ·  catherine.chen@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (3)

Hôpital Femme Mère EnfantBron, FranceRecruiting
Service de pédiatrie, CHRU de Nancy - Hôpitaux de BraboisNancy, FranceNot Yet Recruiting
Service de pneumologie pédiatrique, Hôpital Armand TrousseauParis, FranceNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06370962