Status:
COMPLETED
Sleep in Patients With Cystic Fibrosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
8+ years
Brief 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...
Detailed Description
Background In patients with cystic fibrosis (CF), respiratory disease is characterised by a progressive and ineluctable decline in lung function. Sleep-disordered breathing may occur at an early stage...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00804661
Start Date
July 1 2007
End Date
June 1 2009
Last Update
June 3 2010
Active Locations (1)
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1
AP-HP, Armand Trousseau hospital
Paris, France, 75012