NCT02495571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

June 30, 2015

Last Update Submit

October 13, 2015

Conditions

ALSCough

Keywords

ALS and DysphagiaALS and coughcough reflex test

Outcome Measures

Primary Outcomes (4)

  • PCEF of RC in ALS

    Peak of Cough Expiratory Flow during reflex cough in ALS patients

    6 weeks

  • PCEF of VC in ALS

    Peak of Cough Expiratory Flow during volitional cough in ALS patients

    6 weeks

  • PCEF of RC in healthy subjects

    Peak of Cough Expiratory Flow during reflex cough in healthy subjects

    6 weeks

  • PCEF of VC in healthy subjects

    Peak of Cough Expiratory Flow during during volitional cough in healthy subjects

    6 weeks

Secondary Outcomes (1)

  • PCEF of VC in ALS and control group

    8 weeks

Other Outcomes (1)

  • PCEF of RF in ALS and control group

    8 weeks

Study Arms (2)

ALS Patients

EXPERIMENTAL

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

Other: Cough Assessment in ALS Patients

Healthy Subjects

OTHER

Control group matched by aged and sex with the study group

Other: Cough Assessment in ALS Patients

Interventions

Cough Assessment in ALS PatientsOTHER

1. Volitional Cough assessment by spirometer: a) Peak Cough Espiratory Flow (PCEF) 2. Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)

ALS PatientsHealthy Subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ALS
  • Consensus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ospedale San Camillo IRCCS

Venice, Venice, 30126, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21338708BACKGROUND

  • 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.

    PMID: 25238863BACKGROUND

  • 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.

    PMID: 16920152BACKGROUND

  • 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.

    PMID: 22873621BACKGROUND

MeSH Terms

Conditions

CoughDeglutition Disorders

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • IRENE BATTEL

    IRCCS San Camillo, Venezia, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IRENE BATTEL

CONTACT

+393395317706irene.battel@ospedalesancamillo.net

Claudia Enrichi

CONTACT

claudia.enrichi@ospedalesancamillo.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Speech and Language Pathologist

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 13, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

IT(1)