"New Perspectives of Adaptation to NIV in ALS"

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Other: Adaptation and training to Non Invasive Ventilation (NIV)

• Registration Number: NCT02537132
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study First Posted: 2015-09-01
• Primary Completion: 2016-04
• Study Completion: 2018-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• ALS diagnosis according to the criteria of El Escorial;
• Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
• No respiratory infection within 3 months
• Severe disability (ALS-FRS <31);
• Age > 18 years;
• The voluntary participation to the Study.

Exclusion Criteria

-- Previous episodes of pneumothorax;

• Comorbid cardiac and / or renal important
• Severe cognitive impairment;
• Refusal of the patient at the time of Informed Consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Group	Adaptation and training to Non Invasive Ventilation (NIV)	Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
Outpatient Group	Adaptation and training to Non Invasive Ventilation (NIV)	Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic

Primary Outcome Measures

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

Trial Locations

Locations (2)

Michele Vitacca; 🇮🇹 Lumezzane, Brescia, Italy

Paolo Banfi; 🇮🇹 Milan, Italy