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

Tracking Information

• First Submitted Date: September 27, 2007
• First Posted Date: October 1, 2007
• Results First Submitted Date: September 16, 2020
• Results First Posted Date: November 27, 2020
• Last Update Posted Date: November 27, 2020
• Study Start Date: September 2007
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2020)

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

• Original Primary Outcome Measures (submitted: September 27, 2007): 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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
• Official Title: Effect of Noninvasive Positive Pressure Ventilation on Pulmonary Function Testing in Amyotrophic Lateral Sclerosis

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Supportive Care

Condition

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

• 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
• 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

Study Arms

• Active Comparator: High-level ventilation
  Each subject will spend 2 hours receiving high-level noninvasive ventilation.
  Intervention: Device: noninvasive positive pressure ventilation
• Active Comparator: Low-level ventilation
  Each subject will receive 2 hours of low-level noninvasive positive pressure ventilation.
  Intervention: Device: noninvasive positive pressure ventilation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 5, 2020): 8
• Original Estimated Enrollment (submitted: September 27, 2007): 20
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00537446
• Other Study ID Numbers: AAAC7394
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Robert C. Basner, Columbia University
• Study Sponsor: Columbia University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Columbia University
• Verification Date: November 2020