Investigating sleep patterns in children with cystic fibrosis on CFTR modulators
Overview of Circadian Rhythm Disorders in Children With Cystic Fibrosis in the Era of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators
Hospices Civils de Lyon · NCT06370962
This study is trying to see how CFTR medications affect sleep patterns in children with cystic fibrosis, aged 2 to 17, to better understand their sleep issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 3 sites (Bron and 2 other locations) |
| Trial ID | NCT06370962 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore circadian rhythm disorders in children aged 2 to 17 years with cystic fibrosis who are being treated with CFTR modulators. It seeks to gather data on sleep disorders, particularly focusing on chronotype abnormalities, which have been suggested but not thoroughly studied in this population. The study will involve patients from specific cystic fibrosis centers in Lyon, Paris, and Nancy, ensuring a targeted approach to understanding the impact of CFTR modulation on sleep patterns. The findings could provide insights into the quality of life for these patients and inform future care strategies.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 17 years with cystic fibrosis who have been treated with CFTR modulators for at least two months.
Not a fit: Patients who are not receiving CFTR modulators or those whose parents refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of sleep disorders in cystic fibrosis, leading to improved management and quality of life for affected children.
How similar studies have performed: While there is limited data on circadian rhythm disorders specifically in cystic fibrosis, other studies have indicated the presence of sleep disorders in this population, suggesting a potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with cystic fibrosis * Aged from 2 to 17 years and 11 months * Treated with CFTR modulator Kaftrio-Kalydeco from at least 2 months * Followed in Lyon, Paris-Trousseau or Nancy Cystic Fibrosis Resource and Skill Centres * Non-opposition from both parents Exclusion Criteria: * Parental refusal * Parents unable to comply with protocol requirements at investigator's discretion * Subject participating in interventional research with an exclusion period still in progress at the time of inclusion
Where this trial is running
Bron and 2 other locations
- Hôpital Femme Mère Enfant — Bron, France (RECRUITING)
- Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois — Nancy, France (NOT_YET_RECRUITING)
- Service de pneumologie pédiatrique, Hôpital Armand Trousseau — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Laurianne COUTIER, MD — Service de pneumologie, allergologie, mucoviscidose, Hôpital Femme Mère Enfant, HCL
- Study coordinator: Laurianne COUTIER, MD
- Email: laurianne.coutie@chu-lyon.fr
- Phone: 04 27 85 50 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, cystic fibrosis, Cystic fibrosis transmembrane conductance regulator modulators, circadian rhythm disorders