Assessment of Voluntary and Reflex Cough in Patients With ALS

Brief Title

Assessment of Voluntary and Reflex Cough in Patients With ALS

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

PCEF of RC in ALS

Secondary Outcome

 PCEF of VC in ALS and control group

Condition

ALS

Intervention

Cough Assessment in ALS Patients

Study Arms / Comparison Groups

 ALS Patients
Description:  Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

60

Start Date

October 2015

Completion Date

June 2016

Primary Completion Date

October 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of ALS

          -  Consensus

        Exclusion Criteria:

          -  Smokers

          -  Oxygen Therapy

          -  Invasive Ventilation

          -  Allergy of citrus

          -  Asthma
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

IRENE BATTEL, +393395317706, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02495571

Organization ID

TRSLA


Responsible Party

Principal Investigator

Study Sponsor

IRCCS San Camillo, Venezia, Italy


Study Sponsor

IRENE BATTEL, Principal Investigator, IRCCS San Camillo, Venezia, Italy


Verification Date

October 2015