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Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

NCT ID: NCT00537446

Last Updated: 2020-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis Motor Neuron Disease

Keywords

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noninvasive ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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High-level ventilation

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

Group Type ACTIVE_COMPARATOR

noninvasive positive pressure ventilation

Intervention Type 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.

Low-level ventilation

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

Group Type ACTIVE_COMPARATOR

noninvasive positive pressure ventilation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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"BiPAP" (Respironics), variable positive airway pressure (VPAP) (ResMed), bilevel positive airway pressure, noninvasive ventilation BiPAP (Respironics), VPAP (ResMed), bilevel positive airway pressure, noninvasive ventilation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Robert C. Basner

Special Lecturer in Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert C Basner, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Eleanor and Lou Gehrig ALS/MDA Center at Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAC7394

Identifier Type: -

Identifier Source: org_study_id