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

Plain-language summary

This observational study examines circadian rhythm (biological clock) disorders in children with cystic fibrosis who are taking a CFTR modulator (Kaftrio-Kalydeco). It enrolls children aged 2 to 17 years and 11 months with cystic fibrosis who have been on a CFTR modulator for at least 2 months. It is a study with no assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Start date

4/29/2024

Estimated completion

1/29/2026

Countries

France

Related genes

Locations

• Bron, France
• Nancy, France
• Paris, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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