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NCT00537446 · ClinicalTrials.gov registry record · NA

Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis

A NA study, sponsored by Columbia University.

Terminated
Registry status
NA
Development phase
8
Enrollment target

NCT00537446: Clinical Trial NA study, sponsored by Columbia University.

NCT00537446 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00537446, a NA study, was terminated before completion, sponsored by Columbia University.

TERMINATED
Registry status
NA
Development phase
8 participants
Enrollment target

Study 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.

Interventions

  • DEVICE noninvasive positive pressure ventilation

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2007-09
Est. Completion 2012-08
Phase NA
Columbia University

958 total trials

Why NCT00537446 stopped before completion

NCT00537446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which noninvasive positive pressure ventilation is the first listed.

NCT00537446 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00537446 about?

NCT00537446 is a clinical study titled "Effect of Noninvasive Ventilation on Lung Function in Amyotrophic Lateral Sclerosis". 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 a...

What is the current status of trial NCT00537446?

This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2007-09. Estimated completion is 2012-08.

What interventions are being tested in trial NCT00537446?

The interventions under investigation include: noninvasive positive pressure ventilation (DEVICE).

Who is sponsoring clinical trial NCT00537446?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00537446's enrollment target sits among peer trials

8 1976th of 2000 higher than 19 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00537446, the US trial registry maintained by the National Library of Medicine. NCT00537446 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.