Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386464
Status:
COMPLETED
Last Update Posted:
2007-11-09
First Post:
2006-10-10
Brief Title:
Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This is a randomized crossover trial for patient with ALS and mild respiratory involvement Patients with forced vital capacity above 60 of the predicted value can join Patients will be assigned to either start using non-invasive ventilation at night or continue their usual care After three months patients will switch over to the other treatment group For example a patient who was initially assigned to continue their usual care would begin using non-invasive ventilation after three months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None