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Impact of Non Invasive Ventilation on Quality of Sleep

This study has been completed.
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00991536
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 7, 2009
October 7, 2009
January 1987
December 2008   (final data collection date for primary outcome measure)
Daytime arterial blood gases and Polysomnography before and after non invasive ventilation [ Time Frame: Average of 4 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
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Not Provided
 
Impact of Non Invasive Ventilation on Quality of Sleep
Impact of Non Invasive Ventilation on Quality of Sleep

Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but may also have a favorable impact on sleep structure. The investigators reviewed polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with restrictive pulmonary disorders, before and after implementing non-invasive ventilatory support.

Chart review of all patients with predominantly restrictive pulmonary disorders treated for respiratory failure by NIV at our institution between 1987 and 2008.

Data systematically recorded included pulmonary function tests, diurnal arterial blood gases, and polysomnography before and after implementation of nocturnal NIV.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Patients with respiratory failure due to predominantly restrictive disorders submitted to NIV in preparation for long-term home ventilation and assessed between 1987 and 2008 at the Sleep laboratory.

  • Restrictive Pulmonary Disorders
  • Non Invasive Ventilation
Not Provided
Chronic respiratory failure
Patients with restrictive pulmonary disorders leading to progressive hypercapnic respiratory failure and requiring nocturnal non-invasive ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
December 2008
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with restrictive pulmonary disorders (neuro-muscular diseases, chest wall disorders, sequellae of tuberculosis) leading to hypercapnic respiratory failure requiring non invasive ventilation (NIV), investigated according to clinical standards in our institution by polysomnography before and after implementation of NIV

Exclusion Criteria:

  • Patients fulfilling inclusion criteria for whom diagnostic polysomnography and/or polysomnography under NIV were not performed
Both
10 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00991536
B40320084384
No
Rodenstein D. / Professor, Cliniques Universitaires Saint-Luc
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Study Director: Daniel Rodenstein, Professor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP