Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

NCT00537446 | Terminated Results

• 1 other identifier: AAAC7394
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Keywords

noninvasive ventilation

Outcome Measures

Primary Outcomes (3)

• Difference in Pulmonary Function and Respiratory Muscle Pressure Testing

  5 hours

• Difference in Gas Exchange

  5 hours

• Difference in Subjective Dyspnea Between Baseline and the Two Different Ventilator Modes

  5 hours

Study Arms (2)

High-level ventilation

ACTIVE COMPARATOR

Each subject will spend 2 hours receiving high-level noninvasive ventilation.

Device: noninvasive positive pressure ventilation

Low-level ventilation

ACTIVE COMPARATOR

Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.

Device: noninvasive positive pressure ventilation

Interventions

noninvasive positive pressure ventilation DEVICE

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.

Also known as: "BiPAP" (Respironics), variable positive airway pressure (VPAP) (ResMed), bilevel positive airway pressure, noninvasive ventilation

High-level ventilation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Eleanor and Lou Gehrig ALS/MDA Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Interventions

Continuous Positive Airway Pressure; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Robert Basner, MD
• Organization: Columbia University Irving Medical Center

rcb42@cumc.columbia.edu

Study Officials

• Robert C Basner, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Special Lecturer in Medicine

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 27, 2020
• Results First Posted: November 27, 2020

Record last verified: 2020-11

Locations

US (1)