Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
|ClinicalTrials.gov Identifier: NCT00386464|
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : November 9, 2007
Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course.
There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices.
The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function.
Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: noninvasive positive pressure ventilation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement|
|Study Start Date :||April 2002|
|Study Completion Date :||September 2007|
- Decline in forced vital capacity
- quality of life
- respiratory quality of life
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386464
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Noah Lechtzin, MD||Johns Hopkins University|
|Study Chair:||Charles M Wiener, MD||Johns Hopkins University|