Assessment of Voluntary and Reflex Cough in Patients With ALS
Primary Purpose
ALS, Cough
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cough Assessment in ALS Patients
Sponsored by
About this trial
This is an interventional diagnostic trial for ALS focused on measuring ALS and Dysphagia, ALS and cough, cough reflex test
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ALS
- Consensus
Exclusion Criteria:
- Smokers
- Oxygen Therapy
- Invasive Ventilation
- Allergy of citrus
- Asthma
Sites / Locations
- Fondazione Ospedale San Camillo IRCCSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ALS Patients
Healthy Subjects
Arm Description
Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer
Control group matched by aged and sex with the study group
Outcomes
Primary Outcome Measures
PCEF of RC in ALS
Peak of Cough Expiratory Flow during reflex cough in ALS patients
PCEF of VC in ALS
Peak of Cough Expiratory Flow during volitional cough in ALS patients
PCEF of RC in healthy subjects
Peak of Cough Expiratory Flow during reflex cough in healthy subjects
PCEF of VC in healthy subjects
Peak of Cough Expiratory Flow during during volitional cough in healthy subjects
Secondary Outcome Measures
PCEF of VC in ALS and control group
Comparison of PCEF of the voluntary cough between the 2 groups
Full Information
NCT ID
NCT02495571
First Posted
June 30, 2015
Last Updated
October 13, 2015
Sponsor
IRCCS San Camillo, Venezia, Italy
1. Study Identification
Unique Protocol Identification Number
NCT02495571
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALS, Cough
Keywords
ALS and Dysphagia, ALS and cough, cough reflex test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALS Patients
Arm Type
Experimental
Arm Description
Study Group: Evaluation of the cough reflex and the voluntary cough by spirometer and nebulizer
Arm Title
Healthy Subjects
Arm Type
Other
Arm Description
Control group matched by aged and sex with the study group
Intervention Type
Other
Intervention Name(s)
Cough Assessment in ALS Patients
Intervention Description
Volitional Cough assessment by spirometer:
a) Peak Cough Espiratory Flow (PCEF)
Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)
Primary Outcome Measure Information:
Title
PCEF of RC in ALS
Description
Peak of Cough Expiratory Flow during reflex cough in ALS patients
Time Frame
6 weeks
Title
PCEF of VC in ALS
Description
Peak of Cough Expiratory Flow during volitional cough in ALS patients
Time Frame
6 weeks
Title
PCEF of RC in healthy subjects
Description
Peak of Cough Expiratory Flow during reflex cough in healthy subjects
Time Frame
6 weeks
Title
PCEF of VC in healthy subjects
Description
Peak of Cough Expiratory Flow during during volitional cough in healthy subjects
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
PCEF of VC in ALS and control group
Description
Comparison of PCEF of the voluntary cough between the 2 groups
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
PCEF of RF in ALS and control group
Description
Comparison of PCEF of the reflex cough between the 2 groups
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ALS
Consensus
Exclusion Criteria:
Smokers
Oxygen Therapy
Invasive Ventilation
Allergy of citrus
Asthma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IRENE BATTEL
Phone
+393395317706
Email
irene.battel@ospedalesancamillo.net
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Enrichi
Email
claudia.enrichi@ospedalesancamillo.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IRENE BATTEL
Organizational Affiliation
IRCCS San Camillo, Venezia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Ospedale San Camillo IRCCS
City
Venice
ZIP/Postal Code
30126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Battel Irene
Phone
3395317706
Email
irene.battel@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
21338708
Citation
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.
Results Reference
background
PubMed Identifier
25238863
Citation
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.
Results Reference
background
PubMed Identifier
16920152
Citation
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.
Results Reference
background
PubMed Identifier
22873621
Citation
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.
Results Reference
background
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Assessment of Voluntary and Reflex Cough in Patients With ALS
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