Impact of Non Invasive Ventilation on Quality of Sleep

Non Invasive Ventilation Clinical Trial

Official title:

Impact of Non Invasive Ventilation on Quality of Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991536
• Other study ID #: B40320084384
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: January 1987
• Est. completion date: December 2008

Study information

• Verified date: October 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Diseases
• Non Invasive Ventilation
• Restrictive Pulmonary Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime arterial blood gases and Polysomnography before and after non invasive ventilation		Average of 4 months	No