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Assessment of Voluntary and Reflex Cough in Patients With ALS

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ClinicalTrials.gov Identifier: NCT02495571
Recruitment Status : Unknown
Verified October 2015 by Irene Battel, IRCCS San Camillo, Venezia, Italy.
Recruitment status was:  Recruiting
First Posted : July 13, 2015
Last Update Posted : October 14, 2015
Sponsor:
Information provided by (Responsible Party):
Irene Battel, IRCCS San Camillo, Venezia, Italy

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.


Condition or disease Intervention/treatment Phase
ALS Cough Other: Cough Assessment in ALS Patients Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Observational Study, Assessing PCEF of the Voluntary and Reflex Cough in Patients With ALS
Study Start Date : October 2015
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALS Patients
Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer
Other: 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
Other: 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)




Primary Outcome Measures :
  1. PCEF of RC in ALS [ Time Frame: 6 weeks ]
    Peak of Cough Expiratory Flow during reflex cough in ALS patients

  2. PCEF of VC in ALS [ Time Frame: 6 weeks ]
    Peak of Cough Expiratory Flow during volitional cough in ALS patients

  3. PCEF of RC in healthy subjects [ Time Frame: 6 weeks ]
    Peak of Cough Expiratory Flow during reflex cough in healthy subjects

  4. PCEF of VC in healthy subjects [ Time Frame: 6 weeks ]
    Peak of Cough Expiratory Flow during during volitional cough in healthy subjects


Secondary Outcome Measures :
  1. PCEF of VC in ALS and control group [ Time Frame: 8 weeks ]
    Comparison of PCEF of the voluntary cough between the 2 groups


Other Outcome Measures:
  1. PCEF of RF in ALS and control group [ Time Frame: 8 weeks ]
    Comparison of PCEF of the reflex cough between the 2 groups



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of ALS
  • Consensus

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495571


Contacts
Contact: IRENE BATTEL +393395317706 irene.battel@ospedalesancamillo.net
Contact: Claudia Enrichi claudia.enrichi@ospedalesancamillo.net

Locations
Italy
Fondazione Ospedale San Camillo IRCCS Recruiting
Venice, Italy, 30126
Contact: Battel Irene    3395317706    irene.battel@gmail.com   
Sponsors and Collaborators
IRCCS San Camillo, Venezia, Italy
Investigators
Principal Investigator: IRENE BATTEL IRCCS San Camillo, Venezia, Italy

Publications:
Responsible Party: Irene Battel, Speech and Language Pathologist, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier: NCT02495571     History of Changes
Other Study ID Numbers: TRSLA
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Irene Battel, IRCCS San Camillo, Venezia, Italy:
ALS and Dysphagia
ALS and cough
cough reflex test

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms