Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000192482
Ethics application status
Approved
Date submitted
11/02/2016
Date registered
15/02/2016
Date last updated
24/07/2020
Date data sharing statement initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bionic voice reconstruction in dysphonic individuals
Scientific title
Assessment and validation of bionic voice reconstruction in dysphonic individuals
Secondary ID [1] 288336 0
Nil known
Universal Trial Number (UTN)
U1111-1178-6085
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphonia 297311 0
Laryngectomee 297312 0
Aphonia 297313 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297511 297511 0 0
Other physical medicine / rehabilitation
Neurological 297815 297815 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Evaluation of novel computer algorithm that may reconstruct words from recorded partial speech or whispers. Subjects will be asked to speak phonetically balanced sentences for 15 minutes and this will be recorded. Then the computer algorithm will be used to reconstruct speech. The accuracy and rate of reconstruction of the regenerated voice will be rated by both researchers and the subjects. Ultimately the algorithm would be able to be used on a smart phone or device. A single visit only is required. Participants will be invited to hear reconstructed speech samples and rate them subjectively once reconstruction is complete. Files can be emailed to participants.
Intervention code [1] 293889 0
Not applicable
Comparator / control treatment
The participants are only required to provide voice samples. There is no randomisation or control group. Computer based regeneration is completed within a lab without a participant needing to be present.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297323 0
Accuracy of reconstructed voice samples compared to actual voiced sentences. Accuracy assessed by percentage correct measure where number of words correct is calculated vs actual spoken sentence.
Timepoint [1] 297323 0
Single session only
Secondary outcome [1] 320730 0
Rate of reconstructed voice samples compared to normal speech. This will be assessed by asking raters to classify samples as 'real time', 'slower than normal', 'very slow', 'unable to understand'.
Timepoint [1] 320730 0
Single session only

Eligibility
Key inclusion criteria
1) Abnormal voice
2) Able to attempt repeated voice tasks and follow instructions
3) Able to understand and give consent for the study and able to complete self-assessment questionnaire
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Significant pulmonary disease condition
2) Unable to attempt voice tasks or follow instructions
3) Unable to speak English
4) Inability to give informed consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data captured will be de-identified and then analysed through the Engineering Department at Unitec. Reproduced speech will be graded for intelligibility, accuracy of spoken words, volume, quality and speed of reproduction by two blinded researchers. Quantitative statistical analysis will be undertaken on the voice samples and ratings. Statistical analysis will be performed with p values below 0.05 considered significant.
Power Calculation
Based on a 50% difference in expected speech intelligibility between unaltered voices and voice-reconstructed voices, 65 subjects will be able to detect a real difference where power of 80% and significance levels of 0.05 are used. A mix of severity of voice dysfunction would be expected, from mild impairment to aphonia (total loss of voice). This sample size would not allow specific subgroup analysis but will indicate if further subgroup analysis might be useful in future research.
A total of 70 subjects was agreed so that we could aim to broadly recruit 20 subjects each with mild, moderate and severe voice disorders and at least 10 laryngectomee subjects, hence a cohort of 70 subjects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
3/05/2021
Actual
Date of last data collection
Anticipated
3/05/2021
Actual
Sample size
Target
70
Accrual to date
14
Final
Recruitment outside Australia
Country [1] 7584 0
New Zealand
State/province [1] 7584 0
Auckland

Funding & Sponsors
Funding source category [1] 292873 0
University
Name [1] 292873 0
Unitec Institute of Technology
Country [1] 292873 0
New Zealand
Primary sponsor type
University
Name
Unitec Institute of Technology
Address
Unitec Institute of Technology
Private Bag 92025
Victoria St West
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 291617 0
None
Name [1] 291617 0
none
Address [1] 291617 0
none
Country [1] 291617 0
Other collaborator category [1] 278816 0
University
Name [1] 278816 0
University of Auckland
Address [1] 278816 0
Private Bag 92019
Auckland 1142
Country [1] 278816 0
New Zealand
Other collaborator category [2] 278817 0
Hospital
Name [2] 278817 0
North Shore Hospital
Address [2] 278817 0
Shakespeare Rd
Takapuna
Auckland 0740
Country [2] 278817 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294376 0
Northern B Committee
Ethics committee address [1] 294376 0
Ethics committee country [1] 294376 0
New Zealand
Date submitted for ethics approval [1] 294376 0
18/11/2014
Approval date [1] 294376 0
21/01/2015
Ethics approval number [1] 294376 0
14/NTB/192

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

Contacts
Principal investigator
Name 54286 0
Dr Jacqueline Allen
Address 54286 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Waitemata District Healthboard work location
Country 54286 0
New Zealand
Phone 54286 0
+6421897444
Fax 54286 0
+6495222224
Email 54286 0
[email protected]
Contact person for public queries
Name 54287 0
Jacqueline Allen
Address 54287 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 54287 0
New Zealand
Phone 54287 0
+6421897444
Fax 54287 0
+6495222224
Email 54287 0
[email protected]
Contact person for scientific queries
Name 54288 0
Jacqueline Allen
Address 54288 0
Auckland Voice and Swallow
PO Box 99743
Newmarket
Auckland 1149
Country 54288 0
New Zealand
Phone 54288 0
+6421897444
Fax 54288 0
+6495222224
Email 54288 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
Trademark and patent applications are pending on the software analysis of the voice samples.


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.