Assessment of Voluntary and Reflex Cough in Patients With ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
- 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.
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.
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: ALS Patients
Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer
Other: Cough Assessment in ALS Patients
Control group matched by aged and sex with the study group
Other: Cough Assessment in ALS Patients
- PCEF of RC in ALS [ Time Frame: 6 weeks ]Peak of Cough Expiratory Flow during reflex cough in ALS patients
- PCEF of VC in ALS [ Time Frame: 6 weeks ]Peak of Cough Expiratory Flow during volitional cough in ALS patients
- PCEF of RC in healthy subjects [ Time Frame: 6 weeks ]Peak of Cough Expiratory Flow during reflex cough in healthy subjects
- PCEF of VC in healthy subjects [ Time Frame: 6 weeks ]Peak of Cough Expiratory Flow during during volitional cough in healthy subjects
- PCEF of VC in ALS and control group [ Time Frame: 8 weeks ]Comparison of PCEF of the voluntary cough between the 2 groups
- PCEF of RF in ALS and control group [ Time Frame: 8 weeks ]Comparison of PCEF of the reflex cough between the 2 groups
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
|Contact: IRENE BATTELfirstname.lastname@example.org|
|Contact: Claudia Enrichiemail@example.com|
|Fondazione Ospedale San Camillo IRCCS||Recruiting|
|Venice, Italy, 30126|
|Contact: Battel Irene 3395317706 firstname.lastname@example.org|
|Principal Investigator:||IRENE BATTEL||IRCCS San Camillo, Venezia, Italy|