"New Perspectives of Adaptation to NIV in ALS"

NCT02537132 | Completed

• 1 other identifier: FDG_ALS1H_01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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)

Keywords

Non Invasive Ventilation (NIV); Amyotrophic Lateral sclerosis (ALS); adaptation; home care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Home Group; Outpatient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Salvatore Maugeri: collaborator

Study Sites (2)

Michele Vitacca

Lumezzane, Brescia, 25065, Italy

Location

Paolo Banfi

Milan, 20149, Italy

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: January 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

IT (2)