CompletedNot Applicable

Sleep in Patients With Cystic Fibrosis

France76 participantsStarted 2007-07

Plain-language summary

The aim of the study is to identify the parameters that are associated with nocturnal hypoventilation in children and adults with cystic fibrosis. Included patients will undergo a nocturnal evaluation of their gas exchange and sleep quality by actigraphy during their annual check up. The aim is thus to identify which parameters (such as lung function parameters) are associated with nocturnal hypercapnia or hypoxemia and/or poor sleep quality

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * children \> 8 years and adults with CF * in a stable state (no acute respiratory exacerbation since one month or patient finishing an antibiotic course) * able to perform reproducible forced expiratory flows * having a forced expiratory volume in one second ≤ 60% predicted value * who accepts to perform a sleep study in the hospital during one night * written agreement to participate to the study Exclusion Criteria: * acute respiratory exacerbation in the previous month or patient who has not finished an antibiotic course * Inability or impossibility to perform reproducible forced expiratory flows (pneumothorax during the previous year and/or without surgery) * having a forced expiratory volume in one second \> 60% predicted value * refusal or impossibility to perform a sleep study in the hospital during one night * patients receiving long term oxygen therapy or noninvasive positive pressure ventilation * no social security * impossibility of a medical examination

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine clinical and functional parameters associated with nocturnal hypoventilation defined by· - A mean transcutaneous carbon dioxide pressure (PtcCO2) ≥ 45 mm Hg· - And/or a maximal PtcCO2 ≥ 55 mm Hg· - And/or a PtcCO2 ≥ 45 mm Hg during ≥ 50%

Timeframe: At the inclusion visit

Trial details

NCT IDNCT00804661

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Cystic Fibrosis trials