"New Perspectives of Adaptation to NIV in ALS"

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Other: Adaptation and training to Non Invasive Ventilation (NIV)

Study type: Interventional

Funder types: Other

Identifiers

NCT02537132

FDG_ALS1H_01

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Home Group

Experimental group

Description:

Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home

Treatment:

Other: Adaptation and training to Non Invasive Ventilation (NIV)

Outpatient Group

Active Comparator group

Description:

Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic

Treatment:

Other: Adaptation and training to Non Invasive Ventilation (NIV)