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Assessment of Voluntary and Reflex Cough in Patients With ALS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02495571
Enrollment
60
Registered
2015-07-13
Start date
2015-10-31
Completion date
2016-06-30
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS, Cough

Keywords

ALS and Dysphagia, ALS and cough, cough reflex test

Brief summary

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

Protocol: 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.

Interventions

OTHERCough 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)

Sponsors

IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of ALS * Consensus

Exclusion criteria

* Smokers * Oxygen Therapy * Invasive Ventilation * Allergy of citrus * Asthma

Design outcomes

Primary

MeasureTime frameDescription
PCEF of RC in ALS6 weeksPeak of Cough Expiratory Flow during reflex cough in ALS patients
PCEF of VC in ALS6 weeksPeak of Cough Expiratory Flow during volitional cough in ALS patients
PCEF of RC in healthy subjects6 weeksPeak of Cough Expiratory Flow during reflex cough in healthy subjects
PCEF of VC in healthy subjects6 weeksPeak of Cough Expiratory Flow during during volitional cough in healthy subjects

Secondary

MeasureTime frameDescription
PCEF of VC in ALS and control group8 weeksComparison of PCEF of the voluntary cough between the 2 groups

Other

MeasureTime frameDescription
PCEF of RF in ALS and control group8 weeksComparison of PCEF of the reflex cough between the 2 groups

Countries

Italy

Contacts

Primary ContactIRENE BATTEL
irene.battel@ospedalesancamillo.net+393395317706
Backup ContactClaudia Enrichi
claudia.enrichi@ospedalesancamillo.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026