Sleep in Patients With Cystic Fibrosis - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00804661

Purpose

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

Condition	Intervention
Cystic Fibrosis	Device: SENTEC device

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Predictors of Nocturnal Hypoventilation in Patients With Cystic Fibrosis

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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% [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine clinical and functional parameters associated with- sleep -disordered breathing defined by the presence of arousals on actigraphy (Actiwatch™) in children and adults with CF - nocturnal hypoxemia defined by -- a mean pulse oximetry (SaO2) [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	July 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Children and adults with cystic fibrosis	Device: SENTEC device Nocturnal recording SAO2 and PtcCO2 and wrist movements by means of actigraphy

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 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.

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients from the pneumology centers participating to the study

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804661

Contacts

Contact: Brigitte Fauroux, MD

+33 (0) 1 44 73 61 74

brigitte.fauroux@trs.aphp.fr

Locations

France
AP-HP, Armand Trousseau hospital	Recruiting
Paris, France, 75012
Contact: Brigitte Fauroux, MD +33 (0) 1 44 73 61 74 brigitte.fauroux@trs.aphp.fr
Principal Investigator: Brigitte Fauroux, MD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Brigitte Fauroux, MD

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Yannick Vacher )
Study ID Numbers:	P070202
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00804661
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

sleep
nocturnal hypoventilation
sleep quality
lung function

Study placed in the following topic categories:

Fibrosis
Respiration Disorders
Hypoventilation
Signs and Symptoms
Digestive System Diseases
Respiratory Insufficiency
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009