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"New Perspectives of Adaptation to NIV in ALS"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 28, 2015
First Posted Date  ICMJE September 1, 2015
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "New Perspectives of Adaptation to NIV in ALS"
Official Title  ICMJE "New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Home Group
    Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home
    Intervention: Other: Adaptation and training to Non Invasive Ventilation (NIV)
  • Active Comparator: Outpatient Group
    Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic
    Intervention: Other: Adaptation and training to Non Invasive Ventilation (NIV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2018
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02537132
Other Study ID Numbers  ICMJE FDG_ALS1H_01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondazione Don Carlo Gnocchi Onlus
Study Sponsor  ICMJE Fondazione Don Carlo Gnocchi Onlus
Collaborators  ICMJE Fondazione Salvatore Maugeri
Investigators  ICMJE Not Provided
PRS Account Fondazione Don Carlo Gnocchi Onlus
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP