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Trial record 47 of 488 for:    ALS (Amyotrophic Lateral Sclerosis)

"New Perspectives of Adaptation to NIV in ALS"

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ClinicalTrials.gov Identifier: NCT02537132
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Other: Adaptation and training to Non Invasive Ventilation (NIV) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: Home Group
Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
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.

Active Comparator: Outpatient Group
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)
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 Measures :
  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) [ Time Frame: Baseline + after 2 and 4 months from the recruitment ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537132


Locations
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Italy
Michele Vitacca
Lumezzane, Brescia, Italy, 25065
Paolo Banfi
Milan, Italy, 20149
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Fondazione Salvatore Maugeri

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Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02537132     History of Changes
Other Study ID Numbers: FDG_ALS1H_01
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Non Invasive Ventilation (NIV)
Amyotrophic Lateral sclerosis (ALS)
adaptation
home care

Additional relevant MeSH terms:
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Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases