Sleep in Patients With Cystic Fibrosis

Status Completed

Clinical Trial 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

Clinical Trial 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 of lung disease and may impair quality of life. Oxygen therapy or noninvasive positive pressure ventilation may improve nocturnal hypoxemia and hypercapnia.Risk factors for nocturnal hypercapnia or hypoxemia are not well identified in patients with CF.

Type of study : prospective, transversal, open

Methods :

During the annual check up, a sleep study will be performed with a nocturnal recording of a least 6 hours of pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2) by the SENTEC device and wrist movements by means of actigraphy. The results of the sleep study will be correlated to·

- clinical scores which evaluate sleep quality (such as the PITTSBURG Sleep Quality Score).·

- respiratory function parameters : lung volumes, forced expiratory of the respiratory muscles: maximal inspiratory and expiratory pressures and the sniff nasal inspiratory pressure.·

- nutritional state with the body mass index z-score·

- the presence of arterial pulmonary hypertension on an echocardiography·

- infectious status (colonisation by Staphylococcus aureus or Pseudomonas aeruginosa) and the CFTR genotype.

Expected results This study should be able to document abnormal nocturnal gas exchange and sleep-disordered breathing in patients with CF in a stable state. The identification of parameters associated with nocturnal hypoventilation and/or poor sleep quality will help to screen those patients who will need a sleep study and treatment such as oxygen therapy or noninvasive positive pressure ventilation. ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00804661
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	July 2007
Completion date	June 2009

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sleep in Patients With Cystic Fibrosis — Sommeil

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms