Speech Therapy in the Management of Chronic Cough
Primary Purpose
Cough, Speech Therapy
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Speech and language intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cough focused on measuring chronic cough, speech and language intervention, difficult-to-treat cough
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 80 years,
- chronic cough lasting more than six months
- earlier thorough diagnosing of cough reason
- unsuccessful cough management despite at least 3 months of earlier treatment
- no symptoms of any airway infection during last 4 weeks.
Exclusion Criteria:
- lack of opportunity to participate in speech therapy sessions
- cough lasting less than 6 months
- active cigarette smoking
- taking ACE inhibitors
- symptoms of airway infection (other than cough).
Sites / Locations
- Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Speech and language intervention
Arm Description
Outcomes
Primary Outcome Measures
Cough severity
measured by Visual Analogue Scale (VAS), range 0-100 mm, the more severe cough , the higher value in VAS score
Secondary Outcome Measures
Cough related quality of life
measured by Leicester Cough Questionnaire (LCQ)- health related Quality of Life Questionnaire dedicaated for patients, who cough; rangeof total LCQ is 3 to 21 points; higher values represent less intense cough
Sensitivity of cough reflex
measured by cough challenge test with capsaicin
Full Information
NCT ID
NCT03457610
First Posted
March 1, 2018
Last Updated
April 14, 2020
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT03457610
Brief Title
Speech Therapy in the Management of Chronic Cough
Official Title
Speech Therapy in the Management of Difficult-to-treat Chronic Cough
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.
Patients with difficult-to treat chronic cough will be offered speech and language intervention as an added therapy. The effectiveness of speech therapy will be measured by changes in cough severity, its influence on quality of life and cough challenge test before and after speech therapy measured in every patient.
Detailed Description
The efficacy of management of chronic cough in adults is limited. Speech and language intervention (speech therapy) is one of the few methods which seem to be useful in management of persistent chronic cough. This method has not been available for patients with cough in Poland so far.
The aim of the study is to implement speech therapy to the management plan of patients with difficult-to-treat chronic cough and to analyze its efficacy in this particular group.
Patients, who are diagnosed and unsuccessfully managed because of difficult-to treat chronic cough, will be offered speech and language intervention as an added therapy. It is based on the technique described by Vertigan et al.The entire therapy will consist of eight sessions once a week.
Cough severity, its influence on quality of life and cough challenge test with capsaicin will be assessed by Visual Analogue Scale, Leicester Cough Questionnaire and cough challenge test with capsaicin will be performed before and after speech therapy in every patient to analyze its effectiveness
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Speech Therapy
Keywords
chronic cough, speech and language intervention, difficult-to-treat cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, single arm, single center study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speech and language intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Speech and language intervention
Other Intervention Name(s)
Speech therapy, Voice therapy
Intervention Description
Speech therapy includes education about cough and vocal hygiene, teaching strategies to reduce cough, breathing and vocal exercises. The whole therapy consists of eight sessions once a week.
Primary Outcome Measure Information:
Title
Cough severity
Description
measured by Visual Analogue Scale (VAS), range 0-100 mm, the more severe cough , the higher value in VAS score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Cough related quality of life
Description
measured by Leicester Cough Questionnaire (LCQ)- health related Quality of Life Questionnaire dedicaated for patients, who cough; rangeof total LCQ is 3 to 21 points; higher values represent less intense cough
Time Frame
3 months
Title
Sensitivity of cough reflex
Description
measured by cough challenge test with capsaicin
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 80 years,
chronic cough lasting more than six months
earlier thorough diagnosing of cough reason
unsuccessful cough management despite at least 3 months of earlier treatment
no symptoms of any airway infection during last 4 weeks.
Exclusion Criteria:
lack of opportunity to participate in speech therapy sessions
cough lasting less than 6 months
active cigarette smoking
taking ACE inhibitors
symptoms of airway infection (other than cough).
Facility Information:
Facility Name
Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
17540788
Citation
Morice AH, Fontana GA, Belvisi MG, Birring SS, Chung KF, Dicpinigaitis PV, Kastelik JA, McGarvey LP, Smith JA, Tatar M, Widdicombe J; European Respiratory Society (ERS). ERS guidelines on the assessment of cough. Eur Respir J. 2007 Jun;29(6):1256-76. doi: 10.1183/09031936.00101006. No abstract available.
Results Reference
background
PubMed Identifier
16844725
Citation
Vertigan AE, Theodoros DG, Gibson PG, Winkworth AL. Efficacy of speech pathology management for chronic cough: a randomised placebo controlled trial of treatment efficacy. Thorax. 2006 Dec;61(12):1065-9. doi: 10.1136/thx.2006.064337. Epub 2006 Jul 14.
Results Reference
background
PubMed Identifier
26426314
Citation
Gibson P, Wang G, McGarvey L, Vertigan AE, Altman KW, Birring SS; CHEST Expert Cough Panel. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016 Jan;149(1):27-44. doi: 10.1378/chest.15-1496. Epub 2016 Jan 6.
Results Reference
result
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Speech Therapy in the Management of Chronic Cough
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