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NCT01363882 · ClinicalTrials.gov registry record · NA
Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
A NA study, sponsored by Columbia University.
- Terminated
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01363882: Clinical Trial NA study, sponsored by Columbia University.
NCT01363882 is a NA study that was terminated before completion, run by Columbia University. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01363882, a NA study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Use of noninvasive ventilation (NIV, also known colloquially as "Bipap") has been associated in some studies with improvement in pulmonary function, quality of life and survival. NIV is typically applied during sleep, and without the benefit of sleep study to determine the optimal settings. The investigators have shown that when NIV is used in this fashion, failure of nocturnal oxygenation and ventilation is prominent. This study is randomizing patients to standard application of NIV vs application guided by use of sleep study data to determine the effect of titrated therapy on pulmonary function, quality of life and survival.
Primary Outcome
FVC (forced vital capacity), FEV1 (forced expiratory volume in 1 second), MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure
Interventions
- OTHER Sleep study-guided adjustment of NIV
- OTHER Standard initiation of NIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-07 |
| Phase | NA |
Why NCT01363882 stopped before completion
NCT01363882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Sleep study-guided adjustment of NIV is the first listed.
NCT01363882 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01363882 about?
NCT01363882 is a clinical study titled "Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)". Use of noninvasive ventilation (NIV, also known colloquially as "Bipap") has been associated in some studies with improvement in pulmonary function, quality of life and survival. NIV is typically applied during sleep, and without the benefit of sleep study to determine the optimal settings. The inve...
What is the current status of trial NCT01363882?
This trial is currently terminated. It is a NA study. The enrollment target is 25 participants. The study started on 2008-02. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01363882?
The interventions under investigation include: Sleep study-guided adjustment of NIV (OTHER), Standard initiation of NIV (OTHER).
Who is sponsoring clinical trial NCT01363882?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01363882's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 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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