Sleep in Patients With Cystic Fibrosis (Sommeil)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00804661
First received: December 8, 2008
Last updated: June 2, 2010
Last verified: May 2010
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 76
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: June 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
Other Name: Nocturnal SAO2/PtcCO2 and wrist movements

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
AP-HP, Armand Trousseau hospital
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Brigitte Fauroux, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00804661     History of Changes
Other Study ID Numbers: P070202
Study First Received: December 8, 2008
Last Updated: June 2, 2010
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
sleep
nocturnal hypoventilation
sleep quality
lung function

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Hypoventilation
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Respiratory Insufficiency
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014