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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
  Purpose

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.


Condition
Restrictive Pulmonary Disorders
Non Invasive Ventilation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Impact of Non Invasive Ventilation on Quality of Sleep

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Daytime arterial blood gases and Polysomnography before and after non invasive ventilation [ Time Frame: Average of 4 months ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: January 1987
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic respiratory failure
Patients with restrictive pulmonary disorders leading to progressive hypercapnic respiratory failure and requiring nocturnal non-invasive ventilation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991536

Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Director: Daniel Rodenstein, Professor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Rodenstein D. / Professor, Cliniques Universitaires Saint-Luc
ClinicalTrials.gov Identifier: NCT00991536     History of Changes
Other Study ID Numbers: B40320084384
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013