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Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT00537446
Recruitment Status : Unknown
Verified October 2011 by Columbia University.
Recruitment status was:  Recruiting
First Posted : October 1, 2007
Last Update Posted : October 13, 2011
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Motor Neuron Disease Device: noninvasive positive pressure ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis
Study Start Date : September 2007
Estimated Primary Completion Date : August 2012


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537446


Contacts
Contact: Amy D Atkeson, MD 212-305-7591 ad720@columbia.edu
Contact: Robert C Basner, MD 212-305-7591

Locations
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
Investigators
Principal Investigator: Robert C Basner, MD Columbia University

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00537446     History of Changes
Other Study ID Numbers: AAAC7394
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Columbia University:
noninvasive ventilation

Additional relevant MeSH terms:
Sclerosis
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