Study of Standard Noninvasive Positive Pressure Ventilation (NIPPV) and Low Expiratory Pressure NIPPV in ALS Patients

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of the study is to test whether noninvasive positive pressure ventilation (NIPPV) without expiratory positive airway pressure (EPAP) (inspiratory positive airway pressure (IPAP)-only) will result in an increase in patient usage of NIPPV compared with standard, Bi-level NIPPV. Secondarily, the investigators will assess measures of dyspnea, quality of life, patient satisfaction, and side effects.

Key facts

Study ID

NCT01154283

Run by

Kirsten Gruis

People needed

28

Starts

2008-01-01

Expected to finish

2011-10-01

Last updated by the study team

2017-01-02

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18 years
• Definite or probable ALS by El Escorial criteria
• Maximal inspiratory force < 60 cm/H2O or FVC <50% predicted (American College of Chest Physicians' criteria for initiating NIPPV)
• Patients must have used NIPPV (typically administered as BiPAP) for at least 2 months
• Currently using NIPPV ≥5 days a week with an EPAP = 4 cm H2O.

You may not qualify if…

• Any medical condition that will interfere with participation
• Inability to consent for him/herself
• Known obstructive sleep apnea or obstructive pulmonary disease.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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