Interventional {{label}}

New Perspectives of Adaptation to NIV in ALS


Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.

Primary Outcome Measures:
Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV) [ Time Frame: Baseline + after 2 and 4 months from the recruitment ] [ Designated as safety issue: Yes ]
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month

Exclusion Criteria:
Previous Episodes of Pneumothorax; Comorbid Cardiac and/or Renal Important; Severe Cognitive Impairment; Refusal of Patient at Time of Informed Consent

18 Years and Older, Both Genders, No Healthy Volunteers, ALS-FRS >31

Locations
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