Trial Review

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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] 287857 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SPECC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Cough 1546 0
Condition category
Condition code
Respiratory 1645 1645 0 0
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] 1558 0
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] 2271 0
Cough Reflex Sensitivity (C5)
Timepoint [1] 2271 0
Baseline (0) and 1 hour and after 4-5 sessions of speech therapy
Secondary outcome [1] 3976 0
Cough monitor (frequency)
Timepoint [1] 3976 0
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?
No
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
72
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1791 0
University
Name [1] 1791 0
Faculty of Health/Department of Respiratory Medicine, University of Newcastle
Country [1] 1791 0
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] 1611 0
None
Name [1] 1611 0
Nil
Address [1] 1611 0
Country [1] 1611 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3346 0
Hunter New England Human Research Ethics Committee of Hunter New England Health
Ethics committee address [1] 3346 0
Ethics committee country [1] 3346 0
Australia
Date submitted for ethics approval [1] 3346 0
Approval date [1] 3346 0
13/12/2006
Ethics approval number [1] 3346 0
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] 630 630 0 0
/AnzctrAttachments/81812-SPECC Study Publication, Cough, 2010.pdf

Contacts
Principal investigator
Name 27492 0
Dr Nicole M Ryan
Address 27492 0
Clinical Toxicology Research Group, the University of Newcastle
Level 5, New Med Building, Calvary Mater Newcastle
Edith Street, Waratah, NSW 2298.
Country 27492 0
Australia
Phone 27492 0
+61249211312
Fax 27492 0
Email 27492 0
[email protected]
Contact person for public queries
Name 10747 0
Dr Nicole M Ryan
Address 10747 0
Clinical Toxicology Research Group, the University of Newcastle
Level 5, New Med Building, Calvary Mater Newcastle
Edith Street, Waratah, NSW 2298.
Country 10747 0
Australia
Phone 10747 0
+61249211312
Fax 10747 0
+61240143873
Email 10747 0
[email protected]
Contact person for scientific queries
Name 1675 0
Prof Professor Peter Gibson
Address 1675 0
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 1675 0
Australia
Phone 1675 0
+61 2 49855766
Fax 1675 0
+61 2 49855850
Email 1675 0
[email protected]

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.