"New Perspectives of Adaptation to NIV in ALS"

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537132
• Other study ID #: FDG_ALS1H_01
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Michele Vitacca	Lumezzane	Brescia
Italy	Paolo Banfi	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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