Progression of Respiratory Dysfunction in Amyotrophic Lateral Sclerosis (ALS) Patients: A Comparison of Standard of Practice vs Polysomnography-Directed Nocturnal Non-Invasive Positive Pressure Ventilation

Study 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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis (ALS)

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

Sleep study-guided adjustment of NIV, Standard initiation of NIV

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Robert C Basner, MD, Columbia University

Clinicaltrials.gov ID:

NCT01363882

Neals Affiliated?

No

Coordinating Center Contact Information

Full Study Summary: