Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators
This study investigates how certain medications for cystic fibrosis (CF), specifically CFTR modulators like Kaftrio-Kalydeco, might affect sleep patterns in children. People with CF sometimes have problems with their sleep, including when they feel most awake or tired during the day, which doctors sometimes call their 'chronotype'. This study aims to understand if these new and very effective CF medicines change these sleep patterns. While these treatments greatly improve lung health, some patients have reported changes in their daily rhythms. Understanding these effects is important because sleep problems can impact a child's health, learning, and overall well-being. Finding these problems early could help doctors adjust treatment to improve quality of life for children with CF.
At a glance
What is this study about?
Cystic fibrosis (CF) is a condition that affects many parts of the body, and while new medicines have greatly improved the lives of people with CF, it can still have a big impact on their daily lives. We know that many children with CF can have trouble sleeping, not just because of breathing issues, but also problems like difficulty falling or staying asleep. Every person has a natural body clock that makes them feel more energetic at certain times of the day – some are early birds, others are night owls. This is called a 'chronotype'. We don't fully understand if CF affects this natural body clock.
Recently, very effective new medicines called CFTR modulators, such as Kaftrio-Kalydeco, have been developed for CF. These medicines have made a huge difference to lung health. However, some children and adults taking them have reported changes in their sleep patterns or daily rhythms, sometimes feeling more tired or awake at different times than before. This study wants to specifically look at whether these new CF treatments change children's chronotypes. We think that children taking these medicines might tend to go to sleep later than usual.
Understanding how these medicines affect sleep and daily rhythms is really important because sleep problems can impact a child's energy levels, how well they learn at school, their immune system, and their general health. If we can identify these changes early, doctors might be able to suggest small adjustments, like changing when a child takes their medicine, to help manage these effects and improve their overall quality of life.
Key takeaways
- The study looks at sleep patterns in children with CF.
- It focuses on children taking new CFTR modulator medicines.
- The goal is to see if these medicines affect their natural body clock.
- Understanding this could help improve children's overall health.
- Participation involves observation, not new treatments.
- Early detection could lead to simple adjustments in care.
Who may be eligible?
This study is looking for children with cystic fibrosis (CF) who are between 2 and 17 years and 11 months old. They should be currently taking the CF medicine called Kaftrio-Kalydeco and have been on it for at least two months.
The children need to be cared for at one of the following CF centres: Lyon, Paris-Trousseau, or Nancy. Also, both parents must agree for their child to take part in the study.
Children won't be able to join if their parents don't agree, if the study team thinks the parents won't be able to follow the study instructions, or if the child is currently involved in another research study that prevents them from joining this one.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child between 2 and 17 years old?
- Does my child have cystic fibrosis?
- Is my child currently taking Kaftrio-Kalydeco and has been for at least 2 months?
- Is my child cared for at the CF centre in Lyon, Paris-Trousseau, or Nancy?
- Do both parents agree for my child to take part?
What does participation involve?
The detailed steps for participating in this study are not fully described in the summary provided. However, generally, if your child is eligible, participation would likely involve visits to their CF centre for assessments. These assessments might include questionnaires about sleep habits, wearing a small device (called an actimeter) on their wrist to track their movement and sleep-wake cycles, and possibly collecting urine samples to measure a sleep hormone called melatonin. The study aims to detect sleep rhythm problems, and if found, suggest simple changes like adjusting the timing of Kaftrio-Kalydeco medicine. The total duration of participation and specific follow-up schedules are not detailed but would be explained in full if you decide to inquire further.
Potential risks and benefits
Locations (3)
- Hôpital Femme Mère EnfantVerified postcodeBron, France· Recruiting
- Service de pédiatrie, CHRU de Nancy - Hôpitaux de BraboisVerified postcodeNancy, France· Not yet recruiting
- Service de pneumologie pédiatrique, Hôpital Armand TrousseauVerified postcodeParis, France· Not yet recruiting
Common questions
What is a 'chronotype'?
It's your body's natural tendency to be a "morning person" or a "night owl" – when you feel most awake and sleepy.
What are CFTR modulators?
These are new medicines, like Kaftrio-Kalydeco, that specifically target the root cause of cystic fibrosis to improve health.
Why is sleep important for children with CF?
Good sleep is vital for their energy, learning, immune system, and general well-being and growth.
Will my child have to take new medicine in this study?
No, this study is observing children already taking Kaftrio-Kalydeco; no new medications are being tested.
What might happen if my child has a sleep rhythm problem?
The study hopes to identify these issues so doctors can suggest simple adjustments, such as changing when the CF medicine is taken.
How to find out more
Laurianne COUTIER, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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