NCT03457610

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

March 1, 2018

Last Update Submit

April 14, 2020

Conditions

CoughSpeech Therapy

Keywords

chronic coughspeech and language interventiondifficult-to-treat cough

Outcome Measures

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

    3 months

Secondary Outcomes (2)

  • Cough related quality of life

    3 months

  • Sensitivity of cough reflex

    3 months

Study Arms (1)

Speech and language intervention

EXPERIMENTAL
Behavioral: Speech and language intervention

Interventions

Speech and language interventionBEHAVIORAL

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
Speech and language intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Related Publications (3)

  • 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.

    PMID: 17540788BACKGROUND

  • 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.

    PMID: 16844725BACKGROUND

  • 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.

    PMID: 26426314RESULT

MeSH Terms

Conditions

CoughCommunication DisordersChronic CoughSpeech

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersMental DisordersVerbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective, single arm, single center study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 7, 2018

Study Start

January 1, 2016

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

PL(1)