Amyotrophic Lateral Sclerosis (ALS)
Conditions
Keywords
Non Invasive Ventilation (NIV), Amyotrophic Lateral sclerosis (ALS), adaptation, home care
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.
Interventions
OTHERAdaptation 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.
Sponsors
Fondazione Salvatore Maugeri
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
Italy
Outcome results
None listed