Impact of Non Invasive Ventilation on Quality of Sleep

NCT00991536 | Completed

• 1 other identifier: B40320084384
• Study Type: observational
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Restrictive Pulmonary Disorders; Non Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• Daytime arterial blood gases and Polysomnography before and after non invasive ventilation

  Average of 4 months

Study Arms (1)

Chronic respiratory failure

Patients with restrictive pulmonary disorders leading to progressive hypercapnic respiratory failure and requiring nocturnal non-invasive ventilation

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Officials

• Daniel Rodenstein, Professor

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: January 1, 1987
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 8, 2009

Record last verified: 2009-10