"New Perspectives of Adaptation to NIV in ALS" | NCT02537132 | Trialant

"New Perspectives of Adaptation to NIV in ALS" | NCT02537132 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home Group	Experimental	Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home	Other: Adaptation and training to Non Invasive Ventilation (NIV)
Outpatient Group	Active Comparator	Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic	Other: Adaptation and training to Non Invasive Ventilation (NIV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adaptation and training to Non Invasive Ventilation (NIV)	Other	Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.	Baseline + after 2 and 4 months from the recruitment

Condition Browse Module

Intervention Browse Module