"New Perspectives of Adaptation to NIV in ALS"

NCT ID: NCT02537132

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home Group

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

Group Type: EXPERIMENTAL

Adaptation and training to Non Invasive Ventilation (NIV)

Intervention Type: 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.

Outpatient Group

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

Group Type: ACTIVE_COMPARATOR

Adaptation and training to Non Invasive Ventilation (NIV)

Intervention Type: 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.

Interventions

Adaptation and training to Non Invasive Ventilation (NIV)

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Michele Vitacca

Lumezzane, Brescia, Italy

Paolo Banfi

Milan, , Italy

Countries

Italy

Other Identifiers

FDG_ALS1H_01

Identifier Type: -

Identifier Source: org_study_id