Clinical Trial: Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis
Brief 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.
Detailed Summary:
Sponsor: Columbia University
Current Primary Outcome: Difference in pulmonary function and respiratory muscle pressure testing, difference in gas exchange, and difference in subjective dyspnea between baseline and the two different ventilator modes [ Time Frame: 5 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Columbia University
Dates:
Date Received: September 27, 2007
Date Started: September 2007
Date Completion:
Last Updated: October 12, 2011
Last Verified: October 2011
