Assessment of Voluntary and Reflex Cough in Patients With ALS

Study Overview
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Brief Summary
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This study aims to assess the presence and the intensity of voluntary and cough reflex in patients with amyotrophic lateral sclerosis (ALS), comparing the results with the healthy control group. The assessment of the cough is fundamental to verify the mechanism of airways protection which is particularly compromised in ALS patients. Objective parameters of voluntary and reflex cough would be measured by the spirometer. The reflex of cough would be elicited by a solution of citric acid through an ultrasonic nebulizer.

Detailed Description
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Protocol: Volitional Cough assessment by spirometer (Pony FX- Cosmed): a) Forced vital capacity (FVC); b) Volume Tidal; c) Maximum Espiratory Pressure (MEP); d) Maximum Inspiratory Pressure (MIP); e) Peak of Cough Expiratory Flow. Cough Reflex would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali) connected with the spirometer and the nebulizer via a bidirectional valve. It would be measured the Peak of Cough Expiratory Flow. Participants: It would be recruited 60 subjects at the IRCCS Ospedale San Camillo Venezia (Italy). All participants have to provide informed consent independently. The study group is composed by thirty participants with diagnosis of ALS and the severity score of Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS). The control group consist of thirty healthy subjects matched by aged and sex with the study group. Statistical consideration: The variables measured will be summarized by means and standard deviations or by proportions. Numeric variables MIP-MEP-FVC-Vt-PCEF will be analyzed using the Shapiro-Wilk test to verify the normality of distribution. Depending on the outcome, for the comparison between groups will be used or the t-test (parametric) or the test of Mann Whitney (non-parametric) for independent samples.

Official Title
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Pilot Observational Study, Assessing PCEF of the Voluntary and Reflex Cough in Patients With ALS

Conditions
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ALS, Cough

Intervention / Treatment
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* Other: Cough Assessment in ALS Patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ALS Consensus Exclusion Criteria: Smokers Oxygen Therapy Invasive Ventilation Allergy of citrus Asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALS Patients<br>Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer | Other: Cough Assessment in ALS Patients<br>* Volitional Cough assessment by spirometer: a) Peak Cough Espiratory Flow (PCEF) Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)<br>|
| Other: Healthy Subjects<br>Control group matched by aged and sex with the study group | Other: Cough Assessment in ALS Patients<br>* Volitional Cough assessment by spirometer: a) Peak Cough Espiratory Flow (PCEF) Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCEF of RC in ALS | Peak of Cough Expiratory Flow during reflex cough in ALS patients | 6 weeks | 
| PCEF of VC in ALS | Peak of Cough Expiratory Flow during volitional cough in ALS patients | 6 weeks | 
| PCEF of RC in healthy subjects | Peak of Cough Expiratory Flow during reflex cough in healthy subjects | 6 weeks | 
| PCEF of VC in healthy subjects | Peak of Cough Expiratory Flow during during volitional cough in healthy subjects | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCEF of VC in ALS and control group | Comparison of PCEF of the voluntary cough between the 2 groups | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS and Dysphagia, ALS and cough, cough reflex test