Voice DisordersNCT05215301
Assessment of Multidimensional Voice Program (MDVP) Parameters in Workers
An observational study of Voice Disorders and Occupational Problems, run by Fakultas Kedokteran Universitas Indonesia.
Trial summary
MDVP (Multidimensional Voice Program) has several parameters that can assess voice quality objectively, including Base Frequency (F0), Jitter, Shimmer, NHR (Noise to Harmonic Ratio), VTI (Voice Turbulence Index), and ATRI (Amplitude Tremor Intensity Index). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders, Occupational Problems, Work-related Illness
- What is being tested?
- Multidimensional Voice Program
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Jun 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data will be extracted from the MDVP database and hospital medical records. The MDVP database consists of patients examined with MDVP in the Department of ORL-HNS' Larynx-Pharynx clinic of Dr. Cipto Mangunkusumo Hospital, Jakarta.
Who may be able to join
- Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta
- Patients are active workers in Indonesia on the time of MDVP evaluation
- Patients are above the age of 18
- Patients can be either an occupational or non-occupational voice users
Who cannot join
- Patients with incomplete occupational data
- Patient with incomplete MDVP results
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Multidimensional Voice Program (MDVP) Parameters in Occupational and Non-occupational Voice Users: a Secondary Data Analysis
MDVP (Multidimensional Voice Program) has several parameters that can assess voice quality objectively, including Base Frequency (F0), Jitter, Shimmer, NHR (Noise to Harmonic Ratio), VTI (Voice Turbulence Index), and ATRI (Amplitude Tremor Intensity Index). MDVP may provide an objective yet non-invasive and comfortable alternative to assess voice quality - and to some extent, diagnose voice-related abnormalities. The utilization of MDVP in clinical settings is quite common but using it concerning occupational health is rare, especially in Indonesia. No study had reported usage of MDVP to assess voice quality in any occupational voice user group or reported a thorough comparison of MDVP parameters between occupational and non-occupational voice users. With an increase in the realization that voice can be an essential occupational modality, MDVP may become a practical alternative modality in assessing voice quality and occupational-related voice injury in clinical settings. This study will determine any association between occupational voice users and their MDVP parameters from medical records and the MDVP database in Dr Cipto Mangunkusumo Hospital, Jakarta. The study also tries to see whether there is any value in using MDVP to assess voice quality in workers.
Read the detailed description
Data will be extracted from the MDVP database and hospital medical records. The MDVP database consists of patients examined with MDVP in the Department of ORL-HNS' Larynx-Pharynx clinic of Dr. Cipto Mangunkusumo Hospital, Jakarta.
Voice evaluation for all patients in Dr. Cipto Mangunkusuomo Hospital was done using the Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetrics Corp installed on a personal computer. The patients were asked to emit vocal sounds /" a "/ using the tone and intensity of everyday speech. The physicians are obliged to give an example first. The patient's voice was then recorded using a microphone connected to a computer with the MDVP program. Sounds were recorded in a quiet room for at least 3 seconds with the microphone 10 cm from the patient's mouth. The MDVP program will directly analyze the recorded sound. Sound recording is done 3 - 5 times, and the best sound acoustic analysis results are used as the final result. The results are then kept in the program's database inside the computer.
Patients who attend the Larynx-Pharynx clinic for MDVP evaluations are usually those who comes for post-treatment monitoring (e.g., post-laryngoplasty), had been diagnosed with a voice disorders, and or by personal or physicians' request. There are various reasons why patients are being assigned to MDVP evaluations - and all of this information will be gathered and used as a consideration during data analysis. For the sake of practicality, the researcher will only extract MDVP data from the past five years. Other considerations will be made to ensure that the data extracted will represent a reliable comparison between occupation status and how it affects MDVP parameters (see more in "Criteria for subjects"). The study will use total sampling, where all available data that fits the inclusion criteria will be used for analysis.
Inclusion criteria
- Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta
- Patients are active workers in Indonesia on the time of MDVP evaluation
- Patients are above the age of 18
- Patients can be either an occupational or non-occupational voice users Exclusion criteria
- Patients with incomplete occupational data
- Patient with incomplete MDVP results
Data obtained from the database will be evaluated in SPSS v20 software and analysed to produce descriptive and inferential statistics. The inferential statistics will consist of univariate analysis and bivariate analysis (between two variables). All numeric data will be tested for normal distribution using Kolmogorov-Smirnov.
Univariate analysis will be done to see the average, distribution, and frequency of all variables/outcomes which include the participants' demographic information and MDVP parameters. MDVP parameters will be presented as mean score with its standard deviation (or median with range). Bivariate analysis will be done to evaluate the significance between occupational or non-occupational users to their MDVP parameters. Differences between groups will be assessed using independent samples t-test (parametric) or Mann-Whitney (non-parametric). If possible, multivariate analysis will also be conducted using Chi-Square or Fischer test depending on the data distributions.
- Conditions
- Voice Disorders, Occupational Problems, Work-related Illness
- Being tested
- Multidimensional Voice Program
- Keywords
- Multidimensional Voice Disorder, Voice Quality, Occupational Voice Users
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Voice ProgramDiagnostic test
Also called Acoustic Phonation Program, Kay Elemetric Corp MDVP 4500
MDVP (Multidimensional Voice Program) is a computerized acoustic analysis used to analyze sound quality using various parameters. Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetric Corp was used for voice evaluation.
Research subjects were asked to make a vowel sound /"a"/ using the same tone and intensity as the subject's daily speech. The researcher will give an example before letting the research subject tries. Voice recording was done using a microphone connected to a computer with the MDVP program. Voice recording was done in a quiet room for at least 3 seconds with a microphone distance of 10 cm from the mouth of the research subject. The recorded sound will be directly analyzed with the MDVP program. Sound recording was done 3 - 5 times, and the best sound acoustic analysis results were used for the study.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Voice Users | Workers who uses voice extensively during work falls under occupational voice users (e.g. singers, actors, radio announcer, teacher, translator, lawyer). The grouping were made based on references from The Union of the European Phoniatricians Receives: Diagnostic Test: Multidimensional Voice Program | |
| Non-occupational Voice Users | Those who didn't use voice extensively during work falls under non-occupational voice users (motorcycle drivers, daily labor, administrative workers) Receives: Diagnostic Test: Multidimensional Voice Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
F0 (Fundamental Frequency)
Average fundamental frequency for the vocalization measured in Hz
Measured: 3 minutes minimal
Jitter
Jitter refers to a disruption in sound wave frequencies caused by a lack of control over the vibrations of the vocal cords.
Measured: 3 minutes minimal
Shimmer
Shimmer percent gives an evaluation in percent of the variability of the peak-to-peak amplitude within the analyzed voice samples. It represents the relative period-to-period (very short-term) variability of the peak-to-peak amplitude
Measured: 3 minutes minimal
NHR (Noise to Harmonic Ratio)
Noise-to-harmonic ratio is an average ratio of energy of the in-harmonic components in the range 1500-4500 Hz to the harmonic components energy in the rage 70-4500 Hz. It is a general evaluation of the noise present in the vocalization
Measured: 3 minutes minimal
ATRI (Amplitude Tremor Intensity Index)
Amplitude tremor intensity index shows (in percent) the ratio of the amplitude of the most intensive low-frequency amplitude-modulating component (amplitude tremor) to the total amplitude of the analyzed voice signal.
Measured: 3 minutes minimal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhael Yosia, MD, Principal investigator, Department of Community Medicine, Faculty of Medicine Universitas IndonesiaDewi S Soemarko, MD, Study chair, Department of Community Medicine, Faculty of Medicine Universitas IndonesiaMarsen Isbayuputra, MD, Study chair, Department of Community Medicine, Faculty of Medicine Universitas IndonesiaSyahrial M Hutauruk, MD, Study chair, Department of ORL-HNS, Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215301
- Sponsor's protocol ID
- THT003
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will be kept in Cipto Mangunkusumo General Hospital and will only be shared upon official request to the hospital.
Publications
Kosztyla-Hojna B, Rogowski M, Ruczaj J, Pepinski W, Lobaczuk-Sitnik A. An analysis of occupational dysphonia diagnosed in the North-East of Poland. Int J Occup Med Environ Health. 2004;17(2):273-8.
PubMed 15387083Feder RJ. Varix of the vocal cord in the professional voice user. Otolaryngol Head Neck Surg. 1983 Aug;91(4):435-6. doi: 10.1177/019459988309100417.
PubMed 6415594Godino-Llorente JI, Osma-Ruiz V, Saenz-Lechon N, Cobeta-Marco I, Gonzalez-Herranz R, Ramirez-Calvo C. Acoustic analysis of voice using WPCVox: a comparative study with Multi Dimensional Voice Program. Eur Arch Otorhinolaryngol. 2008 Apr;265(4):465-76. doi: 10.1007/s00405-007-0467-x. Epub 2007 Oct 9.
PubMed 17922287
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Multidimensional Voice Program (MDVP) Parameters in Occupational and Non-occupational Voice Users: a Secondary Data Analysis
- ClinicalTrials.gov ID
- NCT05215301
- Acronym / sponsor ID
- THT003
- Conditions
- Voice Disorders, Occupational Problems, Work-related Illness
- Keywords
- Multidimensional Voice Disorder, Voice Quality, Occupational Voice Users
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MDVP (Multidimensional Voice Program) has several parameters that can assess voice quality objectively, including Base Frequency (F0), Jitter, Shimmer, NHR (Noise to Harmonic Ratio), VTI (Voice Turbulence Index), and ATRI (Amplitude Tremor Intensity Index). MDVP may provide an objective yet non-invasive and comfortable alternative to assess voice quality - and to some extent, diagnose voice-related abnormalities. The utilization of MDVP in clinical settings is quite common but using it concerning occupational health is rare, especially in Indonesia. No study had reported usage of MDVP to assess voice quality in any occupational voice user group or reported a thorough comparison of MDVP parameters between occupational and non-occupational voice users. With an increase in the realization that voice can be an essential occupational modality, MDVP may become a practical alternative modality in assessing voice quality and occupational-related voice injury in clinical settings. This study will determine any association between occupational voice users and their MDVP parameters from medical records and the MDVP database in Dr Cipto Mangunkusumo Hospital, Jakarta. The study also tries to see whether there is any value in using MDVP to assess voice quality in workers.
Detailed description
Data will be extracted from the MDVP database and hospital medical records. The MDVP database consists of patients examined with MDVP in the Department of ORL-HNS' Larynx-Pharynx clinic of Dr. Cipto Mangunkusumo Hospital, Jakarta.
Voice evaluation for all patients in Dr. Cipto Mangunkusuomo Hospital was done using the Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetrics Corp installed on a personal computer. The patients were asked to emit vocal sounds /" a "/ using the tone and intensity of everyday speech. The physicians are obliged to give an example first. The patient's voice was then recorded using a microphone connected to a computer with the MDVP program. Sounds were recorded in a quiet room for at least 3 seconds with the microphone 10 cm from the patient's mouth. The MDVP program will directly analyze the recorded sound. Sound recording is done 3 - 5 times, and the best sound acoustic analysis results are used as the final result. The results are then kept in the program's database inside the computer.
Patients who attend the Larynx-Pharynx clinic for MDVP evaluations are usually those who comes for post-treatment monitoring (e.g., post-laryngoplasty), had been diagnosed with a voice disorders, and or by personal or physicians' request. There are various reasons why patients are being assigned to MDVP evaluations - and all of this information will be gathered and used as a consideration during data analysis. For the sake of practicality, the researcher will only extract MDVP data from the past five years. Other considerations will be made to ensure that the data extracted will represent a reliable comparison between occupation status and how it affects MDVP parameters (see more in "Criteria for subjects"). The study will use total sampling, where all available data that fits the inclusion criteria will be used for analysis.
Inclusion criteria
- Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta
- Patients are active workers in Indonesia on the time of MDVP evaluation
- Patients are above the age of 18
- Patients can be either an occupational or non-occupational voice users Exclusion criteria
- Patients with incomplete occupational data
- Patient with incomplete MDVP results
Data obtained from the database will be evaluated in SPSS v20 software and analysed to produce descriptive and inferential statistics. The inferential statistics will consist of univariate analysis and bivariate analysis (between two variables). All numeric data will be tested for normal distribution using Kolmogorov-Smirnov.
Univariate analysis will be done to see the average, distribution, and frequency of all variables/outcomes which include the participants' demographic information and MDVP parameters. MDVP parameters will be presented as mean score with its standard deviation (or median with range). Bivariate analysis will be done to evaluate the significance between occupational or non-occupational users to their MDVP parameters. Differences between groups will be assessed using independent samples t-test (parametric) or Mann-Whitney (non-parametric). If possible, multivariate analysis will also be conducted using Chi-Square or Fischer test depending on the data distributions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational Voice Users | – | Diagnostic Test: Multidimensional Voice ProgramWorkers who uses voice extensively during work falls under occupational voice users (e.g. singers, actors, radio announcer, teacher, translator, lawyer). The grouping were made based on references from The Union of the European Phoniatricians |
| Non-occupational Voice Users | – | Diagnostic Test: Multidimensional Voice ProgramThose who didn't use voice extensively during work falls under non-occupational voice users (motorcycle drivers, daily labor, administrative workers) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be extracted from the MDVP database and hospital medical records. The MDVP database consists of patients examined with MDVP in the Department of ORL-HNS' Larynx-Pharynx clinic of Dr. Cipto Mangunkusumo Hospital, Jakarta.
Key inclusion criteria (4 listed)
- Patients had their medical records and MDVP data available in dr. Cipto Mangunkusumo Hospital, Jakarta
- Patients are active workers in Indonesia on the time of MDVP evaluation
- Patients are above the age of 18
- Patients can be either an occupational or non-occupational voice users
Key exclusion criteria (2 listed)
- Patients with incomplete occupational data
- Patient with incomplete MDVP results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional Voice ProgramAlso: Acoustic Phonation Program, Kay Elemetric Corp MDVP 4500MDVP (Multidimensional Voice Program) is a computerized acoustic analysis used to analyze sound quality using various parameters. Multidimensional Voice Program (MDVP) 4500 produced by Kay Elemetric Corp was used for voice evaluation. Research subjects were asked to make a vowel sound /"a"/ using the same tone and intensity as the subject's daily speech. The researcher will give an example before letting the research subject tries. Voice recording was done using a microphone connected to a computer with the MDVP program. Voice recording was done in a quiet room for at least 3 seconds with a microphone distance of 10 cm from the mouth of the research subject. The recorded sound will be directly analyzed with the MDVP program. Sound recording was done 3 - 5 times, and the best sound acoustic analysis results were used for the study. | Diagnostic test | Non-occupational Voice Users, Occupational Voice Users |
Primary outcome
F0 (Fundamental Frequency)
Time frame: 3 minutes minimal
Average fundamental frequency for the vocalization measured in Hz
Jitter
Time frame: 3 minutes minimal
Jitter refers to a disruption in sound wave frequencies caused by a lack of control over the vibrations of the vocal cords.
Shimmer
Time frame: 3 minutes minimal
Shimmer percent gives an evaluation in percent of the variability of the peak-to-peak amplitude within the analyzed voice samples. It represents the relative period-to-period (very short-term) variability of the peak-to-peak amplitude
NHR (Noise to Harmonic Ratio)
Time frame: 3 minutes minimal
Noise-to-harmonic ratio is an average ratio of energy of the in-harmonic components in the range 1500-4500 Hz to the harmonic components energy in the rage 70-4500 Hz. It is a general evaluation of the noise present in the vocalization
ATRI (Amplitude Tremor Intensity Index)
Time frame: 3 minutes minimal
Amplitude tremor intensity index shows (in percent) the ratio of the amplitude of the most intensive low-frequency amplitude-modulating component (amplitude tremor) to the total amplitude of the analyzed voice signal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Results publication: PubMed 15387083Kosztyla-Hojna B, Rogowski M, Ruczaj J, Pepinski W, Lobaczuk-Sitnik A. An analysis of occupational dysphonia diagnosed in the North-East of Poland. Int J Occup Med Environ Health. 2004;17(2):273-8.
- Results publication: PubMed 6415594Feder RJ. Varix of the vocal cord in the professional voice user. Otolaryngol Head Neck Surg. 1983 Aug;91(4):435-6. doi: 10.1177/019459988309100417.
- Results publication: PubMed 17922287Godino-Llorente JI, Osma-Ruiz V, Saenz-Lechon N, Cobeta-Marco I, Gonzalez-Herranz R, Ramirez-Calvo C. Acoustic analysis of voice using WPCVox: a comparative study with Multi Dimensional Voice Program. Eur Arch Otorhinolaryngol. 2008 Apr;265(4):465-76. doi: 10.1007/s00405-007-0467-x. Epub 2007 Oct 9.
- Individual participant dataSharing planned: No. Individual Participant Data will be kept in Cipto Mangunkusumo General Hospital and will only be shared upon official request to the hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhael Yosia, MD principal investigator
Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Dewi S Soemarko, MD study chair
Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Marsen Isbayuputra, MD study chair
Department of Community Medicine, Faculty of Medicine Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Disorders and Occupational Problems, run by Fakultas Kedokteran Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikhael Yosia, MD (081378778784, mikhael.yosia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F0 (Fundamental Frequency) (time frame: 3 minutes minimal). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215301, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2022.