- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537132
"New Perspectives of Adaptation to NIV in ALS"
August 1, 2018 updated by: Fondazione Don Carlo Gnocchi Onlus
"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Milan, Italy, 20149
- Paolo Banfi
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Brescia
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Lumezzane, Brescia, Italy, 25065
- Michele Vitacca
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home Group
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
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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.
|
Active Comparator: Outpatient Group
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: Baseline + after 2 and 4 months from the recruitment
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The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.
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Baseline + after 2 and 4 months from the recruitment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion
January 1, 2018
Study Registration Dates
First Submitted
August 28, 2015
First Submitted That Met QC Criteria
August 28, 2015
First Posted (Estimate)
September 1, 2015
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDG_ALS1H_01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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