Assessment of Voluntary and Reflex Cough in Patients With ALS
NCT ID: NCT02495571
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-10-31
2016-06-30
Brief Summary
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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.
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Detailed Description
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1. 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.
2. 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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ALS Patients
Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer
Cough Assessment in ALS Patients
1. Volitional Cough assessment by spirometer:
a) Peak Cough Espiratory Flow (PCEF)
2. Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
Healthy Subjects
Control group matched by aged and sex with the study group
Cough Assessment in ALS Patients
1. Volitional Cough assessment by spirometer:
a) Peak Cough Espiratory Flow (PCEF)
2. Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
Interventions
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Cough Assessment in ALS Patients
1. Volitional Cough assessment by spirometer:
a) Peak Cough Espiratory Flow (PCEF)
2. Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
Eligibility Criteria
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Inclusion Criteria
* Consensus
Exclusion Criteria
* Oxygen Therapy
* Invasive Ventilation
* Allergy of citrus
* Asthma
18 Years
80 Years
ALL
Yes
Sponsors
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IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Irene Battel
Speech and Language Pathologist
Principal Investigators
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IRENE BATTEL
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Camillo, Venezia, Italy
Locations
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Fondazione Ospedale San Camillo IRCCS
Venice, Venice, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Widdicombe JG, Addington WR, Fontana GA, Stephens RE. Voluntary and reflex cough and the expiration reflex; implications for aspiration after stroke. Pulm Pharmacol Ther. 2011 Jun;24(3):312-7. doi: 10.1016/j.pupt.2011.01.015. Epub 2011 Feb 19.
Luchesi KF, Kitamua S, Mourao LF. Amyotrophic Lateral Sclerosis survival analysis: Swallowing and non-oral feeding. NeuroRehabilitation. 2014;35(3):535-42. doi: 10.3233/NRE-141149.
Zoccolella S, Beghi E, Palagano G, Fraddosio A, Samarelli V, Lamberti P, Lepore V, Serlenga L, Logroscino G; SLAP registry. Predictors of delay in the diagnosis and clinical trial entry of amyotrophic lateral sclerosis patients: a population-based study. J Neurol Sci. 2006 Dec 1;250(1-2):45-9. doi: 10.1016/j.jns.2006.06.027. Epub 2006 Aug 22.
Miles A, Huckabee ML. Intra- and inter-rater reliability for judgement of cough following citric acid inhalation. Int J Speech Lang Pathol. 2013 Apr;15(2):209-15. doi: 10.3109/17549507.2012.692812. Epub 2012 Aug 8.
Other Identifiers
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TRSLA
Identifier Type: -
Identifier Source: org_study_id
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