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Trial registered on ANZCTR


Registration number
ACTRN12619000158167
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
4/02/2019
Date last updated
16/10/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined speech pathology and amitriptyline treatment for vocal cord dysfunction.
Scientific title
Comparison of combined speech pathology and amitriptyline versus speech pathology alone in the treatment of vocal cord dysfunction: a randomised double-blind placebo controlled trial.
Secondary ID [1] 297230 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vocal Cord Dysfunction 311318 0
Condition category
Condition code
Respiratory 309955 309955 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Amitriptyline 25mg per day for one week, then increased to 50mg per day for one week then increased to maximal dose of 75mg per day for 8 weeks, oral route - oral capsules, combined with speech pathology behavioural intervention. Speech pathology intervention includes education on vocal cord dysfunction and related conditions such as chronic refractory cough, provision of lifestyle strategies, vocal hygiene and behavioural breathing and voice exercises, provided on an individual basis for 5 sessions over 10 weeks, provided by an experienced speech pathologist.
Arm 2 - Placebo medication and identical speech pathology behavioural intervention.
Adherence to medication and speech pathology intervention will be monitored by unused product return (medication) and participant diary and participant explanation and modelling of exercises (speech pathology intervention).
Intervention code [1] 313500 0
Treatment: Drugs
Intervention code [2] 313501 0
Treatment: Other
Comparator / control treatment
Prosolv cellulose placebo , oral route in combination with speech pathology intervention
Control group
Placebo

Outcomes
Primary outcome [1] 318869 0
vocal cord dysfunction symptoms as assessed by - Vocal Cord Dysfunction Questionnaire (VCDQ)
Timepoint [1] 318869 0
Baseline and post treatment - week 11
Secondary outcome [1] 366289 0
throat hypersensitivity symptoms including irritation, pain and obstruction as assessed by an overall composite score on the Laryngeal Hypersensitivity Questionnaire (LHQ)
Timepoint [1] 366289 0
baseline and post treatment - week 11
Secondary outcome [2] 366290 0
auditory - perceptual voice measure using the Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)
Timepoint [2] 366290 0
baseline and post treatment - week 11
Secondary outcome [3] 366291 0
voice quality of life measure using the Voice Handicap Index (VHI)
Timepoint [3] 366291 0
baseline and post treatment - week 11
Secondary outcome [4] 366292 0
anxiety and depression measure using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 366292 0
baseline and post treatment - week 11

Eligibility
Key inclusion criteria
Adults with vocal cord dysfunction diagnosed using laryngoscopy. Diagnosis defined as abnormal adduction of the vocal folds during inspiration or > 50% adduction during expiration.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous speech pathology treatment for vocal cord dysfunction
contraindications for the use of amitriptyline including pregnancy and breast feeding
Lung pathology excluding asthma
progressive neurological condition
structural vocal fold pathology
inability to attend study visits

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)
allocation concealment - central randomisation within the Pharmacy Clinical Trials Unit for active or placebo allocation. Participants and study investigators blinded to allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation. Stratified for age and referral source - ENT or Respiratory Physician
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/10/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13011 0
The Alfred - Prahran
Recruitment postcode(s) [1] 25496 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 301780 0
Hospital
Name [1] 301780 0
The Alfred
Country [1] 301780 0
Australia
Primary sponsor type
University
Name
LaTrobe University
Address
Bundoora, Victoria 3083
Country
Australia
Secondary sponsor category [1] 301522 0
Hospital
Name [1] 301522 0
Alfred Health
Address [1] 301522 0
The Alfred, Commercial Rd Prahran
Victoria 3004
Country [1] 301522 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302496 0
Alfred Health HREC
Ethics committee address [1] 302496 0
Ethics committee country [1] 302496 0
Australia
Date submitted for ethics approval [1] 302496 0
29/01/2019
Approval date [1] 302496 0
03/05/2019
Ethics approval number [1] 302496 0
87/19
Ethics committee name [2] 302516 0
LaTrobe University HREC
Ethics committee address [2] 302516 0
Ethics committee country [2] 302516 0
Australia
Date submitted for ethics approval [2] 302516 0
25/03/2019
Approval date [2] 302516 0
Ethics approval number [2] 302516 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90418 0
Mrs Janine Mahoney
Address 90418 0
Speech Pathology Dept
The Alfred
Commercial Rd
Prahran
Victoria 3004
Country 90418 0
Australia
Phone 90418 0
+61 390763341
Fax 90418 0
Email 90418 0
[email protected]
Contact person for public queries
Name 90419 0
Janine Mahoney
Address 90419 0
Speech Pathology Dept
The Alfred
Commercial Rd
Prahran
Victoria 3004
Country 90419 0
Australia
Phone 90419 0
+61 390763341
Fax 90419 0
Email 90419 0
[email protected]
Contact person for scientific queries
Name 90420 0
Janine Mahoney
Address 90420 0
Speech Pathology Dept
The Alfred
Commercial Rd
Prahran
Victoria 3004
Country 90420 0
Australia
Phone 90420 0
+61 390763341
Fax 90420 0
Email 90420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
group data will be available through publication


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.