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 range8 Years

SexALL

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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

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