Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
Stopped early · Not applicable
Conditions studied: Amyotrophic Lateral Sclerosis, Motor Neuron Disease
In brief
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.
Key facts
- Study ID
- NCT00537446
- Run by
- Columbia University
- People needed
- 8
- Starts
- 2007-09-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2020-11-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Eleanor and Lou Gehrig ALS/MDA Center at Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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