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CompletedNCT03457610Updated Apr 15, 2020

Speech Therapy in the Management of Chronic Cough

An interventional study of Speech and language intervention in Cough and Speech Therapy, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-15.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Cough
  • Speech Therapy

Keywords

  • chronic cough
  • speech and language intervention
  • difficult-to-treat cough
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age between 18 and 80 years,
  2. chronic cough lasting more than six months
  3. earlier thorough diagnosing of cough reason
  4. unsuccessful cough management despite at least 3 months of earlier treatment
  5. no symptoms of any airway infection during last 4 weeks.

Exclusion criteria

Exclusion Criteria:

  1. lack of opportunity to participate in speech therapy sessions
  2. cough lasting less than 6 months
  3. active cigarette smoking
  4. taking ACE inhibitors
  5. symptoms of airway infection (other than cough).
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Speech and language intervention

    Behavioral: Speech and language intervention

Interventions

  • BehavioralSpeech and language intervention

    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.

    Also known as: Speech therapy, Voice therapy

05

What researchers measure

Primary outcomes

  1. Cough severity

    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 outcomes

  1. 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

    Time frame: 3 months

  2. Sensitivity of cough reflex

    measured by cough challenge test with capsaicin

    Time frame: 3 months

06

Study locations

1 site
  • Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
    Warsaw, 02-097, Poland
07

References and documents

Publications

  • 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. PubMed 17540788 ↗
  • 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. PubMed 16844725 ↗
  • 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. PubMed 26426314 ↗
08

Registry details

Key details

Study ID
NCT03457610
Lead sponsor
Medical University of Warsaw
Responsible party
Marta Dąbrowska (Principal Investigator, Medical University of Warsaw) — Principal investigator
First posted
Mar 7, 2018
Start date
Jan 1, 2016
Primary completion
Dec 30, 2019
Completion
Jan 30, 2020
Last update
Apr 15, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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