Back to results"New Perspectives of Adaptation to NIV in ALS"
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Adaptation and training to Non Invasive Ventilation (NIV)
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring Non Invasive Ventilation (NIV), Amyotrophic Lateral sclerosis (ALS), adaptation, home care
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.
Sites / Locations
- Michele Vitacca
- Paolo Banfi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home Group
Outpatient Group
Arm Description
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02537132
First Posted
August 28, 2015
Last Updated
August 1, 2018
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT02537132
Brief Title
"New Perspectives of Adaptation to NIV in ALS"
Official Title
"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2018 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Fondazione Salvatore Maugeri
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
Keywords
Non Invasive Ventilation (NIV), Amyotrophic Lateral sclerosis (ALS), adaptation, home care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Group
Arm Type
Experimental
Arm Description
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
Arm Title
Outpatient Group
Arm Type
Active Comparator
Arm Description
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic
Intervention Type
Other
Intervention Name(s)
Adaptation and training to Non Invasive Ventilation (NIV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
Time Frame
Baseline + after 2 and 4 months from the recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Michele Vitacca
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
Facility Name
Paolo Banfi
City
Milan
ZIP/Postal Code
20149
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
"New Perspectives of Adaptation to NIV in ALS"
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