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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 : Terminated (Insufficient enrollment)
First Posted : October 1, 2007
Results First Posted : November 27, 2020
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Robert C. Basner, Columbia University

Tracking Information
First Submitted Date  ICMJE September 27, 2007
First Posted Date  ICMJE October 1, 2007
Results First Submitted Date  ICMJE September 16, 2020
Results First Posted Date  ICMJE November 27, 2020
Last Update Posted Date November 27, 2020
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 5, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2007)
20
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00537446
Other Study ID Numbers  ICMJE AAAC7394
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert C. Basner, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert C Basner, MD Columbia University
PRS Account Columbia University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP