Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000099729
Ethics application status
Approved
Date submitted
7/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Objective measurement of muscle tension in the throat in individuals with muscle tension dysphonia
Scientific title
Objective measurement of supraglottic constriction and related acoustic correlates in individuals with muscle tension dysphonia
Secondary ID [1] 305910 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Tension Dysphonia (MTD) 324486 0
Condition category
Condition code
Musculoskeletal 321968 321968 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a two-phase study.
Phase 1 - 25 participants (20 with MTD, 5 controls) will be recruited. They will be required to attend a single data collection session that will take up to one hour. All participants will undergo the following: 1) voice assessment (approx. 3 minutes long; sustained production of vowel sound "ee", repetition of the sentence "how hard did he hit him?", and humming), audio will be recorded using a microphone attached to clothing; 2) assessment using flexible endoscopic imaging inserted through the nose and into the throat, including a repeated voice assessment (approx. 5 minutes long; sustained production of vowel sound "ee", repetition of the sentence "how hard did he hit him?", and humming) with endoscope in situ; 3) high-resolution surface electromyography (sEMG; placed on the skin overlaying the neck, approx. 10 minutes to fit) will then be used during a further repetition of the voice assessment (approx. 3 minutes long; sustained production of vowel sound "ee", repetition of the sentence "how hard did he hit him?", and humming); 4) flexible endoscope will be re-placed into the throat (simultaneously with sEMG) and a final voice assessment will be completed (approx. 5 minutes long; sustained production of vowel sound "ee", repetition of the sentence "how hard did he hit him?", and humming). The assessment will be run by a Speech-Language Therapist/PhD student.
Phase 2
5 Speech-Language Therapists (SLT) will be provided with de-identified still images and video files gathered during Phase 1 of the study. The SLTs will use two different methods (subjective and objective software) to measure the amount of muscle tension in the laryngeal muscles. The software is newly developed by members of the research team, and is as yet un-named. The SLTs will use the software to gather objective measurements by measuring number of pixels in endoscopic still images and videos. To do this, the SLTs will measure vocal fold length and width (at anterior 1/3 and halfway point of the vocal folds), which the software will use to calculate total pixel value. Total pixel value will quantify visible vocal fold as an indicator of muscle tension. To determine subjective measures, the SLTs will rate constriction using a scale (0 - no constriction, 1 - mild constriction, 2 - mild-moderate constriction, 3 - moderate constriction, 4 - moderate-severe constriction, 5 - severe constriction, 6 - complete constriction/no visibility of the vocal folds). Participation in this phase of the study will take up to four hours in total. This does not need to be completed in one go, but will need to be completed within one week.
Intervention code [1] 322306 0
Diagnosis / Prognosis
Comparator / control treatment
5 healthy control participants (i.e., without any voice impairment) will be included and will receive the same assessments as the MTD group.

To clarify, this study will use a software to create objective measures of muscle tension seen in both endoscopic images and videos. These objective measures will then be compared to subjective ratings of muscle tension seen in endoscopic images and videos.
Control group
Active

Outcomes
Primary outcome [1] 330059 0
Ratio of vocal fold area (in pixels) between rest and during phonation (rest:phon) using still images gathered during endoscopic assessment
Timepoint [1] 330059 0
Images will be captured at the time of voice assessment during the second endoscope insertion
Primary outcome [2] 330060 0
Pixel value at which 75% of frames sit at or above (taken from the overall pixel value throughout the entire video), using video recorded during endoscopy
Timepoint [2] 330060 0
Videos captured at the time of voice assessment during the second endoscope insertion
Primary outcome [3] 330061 0
Perceived severity of muscle tension on a scale of 0 (no constriction) - 6 (severe constriction), using endoscopic images
Timepoint [3] 330061 0
Images captured at the time of voice assessment during the second endoscope insertion
Secondary outcome [1] 404764 0
Perceived severity of muscle tension on a scale of 0 (no constriction) - 6 (severe constriction), using endoscopic videos
Timepoint [1] 404764 0
Videos captured at the time of voice assessment during the second endoscope insertion
Secondary outcome [2] 404765 0
Cepstral Peak Prominence i.e., a measure of voice quality, using audio files recorded during the second voice assessment/endoscope insertion
Timepoint [2] 404765 0
Audio captured at the time of voice assessment during the second endoscopic insertion
Secondary outcome [3] 404767 0
Harmonics-to-noise ratio i.e., the ratio between periodic and aperiodic components of the voice signal, using audio files recorded during the second voice assessment/endoscope insertion
Timepoint [3] 404767 0
Audio captured at the time of voice assessment during the second endoscope insertion
Secondary outcome [4] 404769 0
High density sEMG:
Myoelectrical activation and coordination, obtained from
- temporal measures (ms)
- spectral measures (Hz)
Timepoint [4] 404769 0
sEMG data will be obtained during the duration of the fourth endoscopy insertion

Eligibility
Key inclusion criteria
Phase 1
MTD group:
- 18 years or older
- Able to give informed consent
- Diagnosed with MTD following an endoscopic voice assessment by an otolaryngologist and
Speech-Language Therapist

Healthy group:
- 18 years or older
- Able to give informed consent

Phase 2:
- 18 years or older
- Able to give informed consent
- Currently practicing as a Speech-Language Therapist in New Zealand
- Currently working with patients with voice disorders
- Current or recent (last six months) experience with interpreting laryngeal examinations on endoscopy/stroboscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
MTD group:
- Lack of observable supraglottic constriction (muscle tension) during diagnostic examination
- Presence of organic lesions or vocal fold pathology e.g. tumours, nodules or polyps
- Smoking or vaping in the last 6 months
- Upper respiratory tract infection (URTI) in the last 2 weeks

Healthy group:
- Current or historic voice disorders
- Acute loss or impairment of voice in the last month e.g. acute laryngitis
- Smoking or vaping in the last 6 months
- Upper respiratory tract infection in the last 2 weeks

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Two phases included in the study
Phase 1: data (endoscopic, acoustic and sEMG) collected from patients with MTD and healthy participants.
Phase 2: endoscopic data analysed by Speech-Language Therapists using objective and subjective measurement methods
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to the pilot nature of this study, a convenience sample of 25 participants will be recruited. Data collected during this study will provide the basis for sample size calculations for future investigations.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 24355 0
New Zealand
State/province [1] 24355 0
Canterbury

Funding & Sponsors
Funding source category [1] 310260 0
University
Name [1] 310260 0
University of Canterbury
Country [1] 310260 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
University of Canterbury Rose Centre for Stroke Recovery and Research
Level 1 Leinster Chambers, St George's Hospital
249 Papanui Rd, Merivale
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 311360 0
None
Name [1] 311360 0
Address [1] 311360 0
Country [1] 311360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309932 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 309932 0
Ethics committee country [1] 309932 0
New Zealand
Date submitted for ethics approval [1] 309932 0
19/08/2021
Approval date [1] 309932 0
10/11/2021
Ethics approval number [1] 309932 0

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

Contacts
Principal investigator
Name 115886 0
Miss Elizabeth Cross
Address 115886 0
UC Rose Centre for Stroke Recovery and Research,
Level 1 Leinster Chambers, 249 Papanui Rd
Merivale
Christchurch 8014
Country 115886 0
New Zealand
Phone 115886 0
+64 3 369 2385
Fax 115886 0
Email 115886 0
[email protected]
Contact person for public queries
Name 115887 0
Elizabeth Cross
Address 115887 0
UC Rose Centre for Stroke Recovery and Research,
Level 1 Leinster Chambers, 249 Papanui Rd
Merivale
Christchurch 8014
Country 115887 0
New Zealand
Phone 115887 0
+64 3 369 2385
Fax 115887 0
Email 115887 0
[email protected]
Contact person for scientific queries
Name 115888 0
Elizabeth Cross
Address 115888 0
UC Rose Centre for Stroke Recovery and Research,
Level 1 Leinster Chambers, 249 Papanui Rd
Merivale
Christchurch 8014
Country 115888 0
New Zealand
Phone 115888 0
+64 3 369 2385
Fax 115888 0
Email 115888 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


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.