Study Purpose:
Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis , Motor Neuron Disease
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
noninvasive positive pressure ventilation
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Robert C Basner, MD, Columbia University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Columbia University
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
New York, New York, 10032 United States
Full Study Summary:
Amyotrophic Lateral Sclerosis (ALS), or "Lou Gehrig's Disease", is a fatal disorder that causes progressive degeneration and weakening of the muscles of breathing, leading to breathing insufficiency and eventually breathing failure. This breathing insufficiency is commonly treated with a breathing assistance device, known as noninvasive positive pressure ventilation (NIPPV). While generally well tolerated and accepted, it is not clear whether or to what extent NIPPV in fact helps breathing function: some data suggest that NIPPV preserves breathing function over time, whereas other data suggest that it actually causes breathing function to decline more quickly. No studies have shown what the acute effect of NIPPV is on breathing muscle function in ALS patients.
This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.
This study will test the hypothesis that the acute use of NIPPV, at pressure levels that are in common clinical use, will cause measurable changes in tests of breathing function, compared to baseline and to lower levels of NIPPV. We expect that the results of this study will help to clarify whether and to what extent NIPPV assists respiratory muscle function in patients with ALS.
Study Sponsor:
Columbia University
Estimated Enrollment:
8
Estimated Study Start Date:
08 / 31 / 2007
Estimated Study Completion Date:
08 / 01 / 2012
Posting Last Modified Date:
11 / 27 / 2020
Date Study Added to neals.org:
10 / 01 / 2007
The recruitment status of this study is unknown because the information has not been verified on clinicaltrials.gov recently.
Minimum Age:
18 Years
Maximum Age:
80 Years
Inclusion Criteria:- clinical diagnosis of amyotrophic lateral sclerosis
- clinical indication to start noninvasive ventilation (forced vital capacity < 50% predicted or signs/symptoms of respiratory insufficiency)
- age 18 to 80 years old
Exclusion Criteria:
- prior institution of NIPPV
- inability to safely use NIPPV
- indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway
- inability or unwillingness to perform pulmonary function testing
- presence of advanced dementia.
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University
New York, New York
10032
United States