ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000053426

Ethics application status

Approved

Date submitted

15/01/2007

Date registered

16/01/2007

Date last updated

10/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of Speech Pathology on Cough Reflex Hypersensitivity in Chronic Cough

Scientific title

Effect of Speech Pathology on Cough Reflex Hypersensitivity in Chronic Cough

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

SPECC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Cough

Condition category

Condition code

Respiratory

Normal development and function of the respiratory system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Speech Pathology involves a number of speciifc breathing and voice exercises that retrain the vocal cords to open on inspiration and close on expiration.
Education/Reassurance, specific strategies for controlling the cough sensation such as swallowing instead of coughing or sipping regular small quantities of water when the sensation to cough arises. Reassurance, involves assuring the subject that their chronic cough is not caused by a fatal disease and that their condition can be improved and even resolved in cases.

Intervention and control treatments have a duration of one hour.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No Intervention, the subject is directed to sit in the waiting room and supplied with reading material.

Control group

Active

Outcomes

Primary outcome [1]

Cough Reflex Sensitivity (C5)

Timepoint [1]

Baseline (0) and 1 hour and after 4-5 sessions of speech therapy

Secondary outcome [1]

Cough monitor (frequency)

Timepoint [1]

Baseline (0) and vsit 2 which is 4-5 sessions of speech therapy completed.

Eligibility

Key inclusion criteria

Chronic cough (> 8 weeks).

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previously undergone speech therapy.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomisation table created by computer software.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

subject is blinded

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

17/01/2007

Actual

5/03/2007

Date of last participant enrolment

Anticipated

Actual

3/08/2009

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Faculty of Health/Department of Respiratory Medicine, University of Newcastle

Address [1]

Callaghan Campus, Newcastle, 2300, NSW

Country [1]

Australia

Primary sponsor type

Individual

Name

Hunter New England Health, Professor Peter Gibson

Address

Hunter Medical Research Institute,
Dept. of Respiratory and Sleep Medicine
Level 3 John Hunter Hospital,
Lookout Road, New Lambton, NSW, 2305

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee of Hunter New England Health

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/12/2006

Ethics approval number [1]

06/11/22/5.05

Summary

Brief summary

This research study will investigate how speech pathology treatments may work for chronic cough.

Chronic cough is a common problem that can be caused by conditions such as asthma, rhinitis and reflux. In approximately 20% of people, chronic cough remains unexplained. Recently we have identified that 50% of chronic cough sufferers have Paradoxical Vocal Cord Movement or Vocal Cord Dysfunction coexisting with chronic cough. Paradoxical vocal movement or vocal cord dysfunction is a condition that results in the vocal cords closing rather than opening when you breathe in. This can cause cough or breathing problems. Paradoxical vocal cord movement can be effectively treated with speech pathology. This study will assess how speech pathology benefits chronic cough.


The purpose of this study is to:- 
(i)      To investigate the effects of various aspects of the speech pathology treatment program on cough reflex sensitivity. 
(ii)     To compare changes in cough reflex sensitivity following single components of the speech pathology intervention e.g. voluntary control versus specific strategies.

It is hypothesised that specific speech pathology treatments will decrease cough reflex hypersensitivity.

Trial website

Trial related presentations / publications

* Ryan NM, Gibson PG. Recent additions in the treatment of cough. J Thorac Dis. 2014; 6 (Suppl 7): S739–S747. doi: 10.3978/j.issn.2072-1439.2014.03.13 
* Gibson PG, Ryan NM. Cough pharmacotherapy: current and future status. Expert Opin Pharmacother. 2011;12(11):1745-55. (Invited Manuscript)
* Ryan NM, Vertigan AE, Bone SL, Gibson PG. Cough reflex sensitivity improves with speech language pathology management of refractory chronic cough. Cough. 2010;6:5.

Public notes

Attachments [1]

/AnzctrAttachments/81812-SPECC Study Publication, Cough, 2010.pdf

Contacts

Principal investigator

Name

Dr Nicole M Ryan

Address

Clinical Toxicology Research Group, the University of Newcastle
Level 5, New Med Building, Calvary Mater Newcastle
Edith Street, Waratah, NSW 2298.

Country

Australia

Phone

+61249211312

Fax

Nicole.Ryan@newcastle.edu.au

Contact person for public queries

Name

Nicole M Ryan

Address

Clinical Toxicology Research Group, the University of Newcastle
Level 5, New Med Building, Calvary Mater Newcastle
Edith Street, Waratah, NSW 2298.

Country

Australia

Phone

+61249211312

Fax

+61240143873

Nicole.Ryan@newcastle.edu.au

Contact person for scientific queries

Name

Professor Peter Gibson

Address

Level 3 Room 3598
School of Medicine and Public Health
Hunter Medical Research Institute
John Hunter Hospital
Lookout Road
New Lambton Heights NSW 2305

Country

Australia

Phone

+61 2 49855766

Fax

+61 2 49855850

Peter.Gibson@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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