Status:
COMPLETED
Study of Standard Noninvasive Positive Pressure Ventilation (NIPPV) and Low Expiratory Pressure NIPPV in ALS Patients
Lead Sponsor:
Kirsten Gruis
Collaborating Sponsors:
ALS Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Subjects will be randomized on a 1:1 basis to one of two groups differing in the sequence of NIPPV settings ((a) standard, Bi-level NIPPV followed by IPAP-only NIPPV or (b) IPAP-only NIPPV followed by...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any medical condition that will interfere with participation
- Inability to consent for him/herself
- Known obstructive sleep apnea or obstructive pulmonary disease.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01154283
Start Date
January 1 2008
End Date
October 1 2011
Last Update
January 2 2017
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109