Expired Study
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New York, New York 10032


Purpose:

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.


Criteria:

Inclusion Criteria: - Diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS) per El Escorial criteria - Between ages of 18 and 80 yrs old Exclusion Criteria: - Inability to clear secretions from the airway - Life expectancy < 6 months from a comorbid condition - Dementia sufficient to impair ability to use NIV, perform respiratory muscle pressure testing (PFTs), or complete Health-related Quality of Life (HRQOL) instruments - Inability to follow up at the ALS Center on a regular basis - Previously diagnosed obstructive Sleep Apnea


NCT ID:

NCT01363882


Primary Contact:

Principal Investigator
Robert C Basner, MD
Columbia University


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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