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Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Columbia University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Columbia University Identifier:
First received: September 27, 2007
Last updated: October 12, 2011
Last verified: October 2011

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.

Condition Intervention
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Device: noninvasive positive pressure ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High-level ventilation
Each subject will spend 2 hours receiving high-level noninvasive ventilation.
Device: noninvasive positive pressure ventilation
Each subject will undergo 2 hours of high-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 12 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
Other Name: "BiPAP" (Respironics), VPAP (ResMed), bilevel positive airway pressure, noninvasive ventilation
Active Comparator: Low-level ventilation
Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.
Device: noninvasive positive pressure ventilation
Each subject will undergo 2 hours of low-level noninvasive positive pressure ventilation, with an inspiratory positive airway pressure of 6 cm H2O and an expiratory positive airway pressure of 3 cm H2O.
Other Name: BiPAP (Respironics), VPAP (ResMed), bilevel positive airway pressure, noninvasive ventilation


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00537446

Contact: Amy D Atkeson, MD 212-305-7591
Contact: Robert C Basner, MD 212-305-7591

United States, New York
Eleanor and Lou Gehrig ALS/MDA Center at Columbia University Recruiting
New York, New York, United States, 10032
Sub-Investigator: Amy D Atkeson, MD         
Sponsors and Collaborators
Columbia University
Principal Investigator: Robert C Basner, MD Columbia University
  More Information

Responsible Party: Columbia University Identifier: NCT00537446     History of Changes
Other Study ID Numbers: AAAC7394
Study First Received: September 27, 2007
Last Updated: October 12, 2011

Keywords provided by Columbia University:
noninvasive ventilation

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases processed this record on May 23, 2017