Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

• ClinicalTrials.gov Identifier: NCT00537446
• Recruitment Status: Terminated
• First Posted: October 1, 2007
• Results First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Sponsor: Columbia University
• Information provided by (Responsible Party): Robert C. Basner, Columbia University

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 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
• Actual Primary Completion Date: August 2012
• Actual Study Completion Date: August 2012

Arms and Interventions

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), variable positive airway pressure (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

Outcome Measures

Primary Outcome Measures :

1. Difference in Pulmonary Function and Respiratory Muscle Pressure Testing [ Time Frame: 5 hours ]
2. Difference in Gas Exchange [ Time Frame: 5 hours ]
3. Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes [ Time Frame: 5 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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.

Contacts and Locations

Locations

United States, New York

Eleanor and Lou Gehrig ALS/MDA Center at Columbia University

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Robert C Basner, MD; Columbia University

More Information

• Responsible Party: Robert C. Basner, Special Lecturer in Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT00537446
• Other Study ID Numbers: AAAC7394
• First Posted: October 1, 2007
• Results First Posted: November 27, 2020
• Last Update Posted: November 27, 2020
• Last Verified: November 2020

Keywords provided by Robert C. Basner, Columbia University:

noninvasive ventilation

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis; Pathologic Processes; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases