Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

Not Applicable

Terminated

• Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease
• Interventions: Device: noninvasive positive pressure ventilation

• Registration Number: NCT00537446
• Lead Sponsor: Columbia University

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 Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-10-01
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2020-09-16
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-05
• Last Update Submitted: 2020-11-05
• Results First Posted: 2020-11-27
• Last Update Posted: 2020-11-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-level ventilation	noninvasive positive pressure ventilation	Each subject will spend 2 hours receiving high-level noninvasive ventilation.
Low-level ventilation	noninvasive positive pressure ventilation	Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

Primary Outcome Measures

Name	Time	Method
Difference in Pulmonary Function and Respiratory Muscle Pressure Testing	5 hours
Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes	5 hours
Difference in Gas Exchange	5 hours

Trial Locations

Locations (1)

Eleanor and Lou Gehrig ALS/MDA Center at Columbia University; 🇺🇸 New York, New York, United States