NCT05215301

Brief 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). 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 18, 2022

Last Update Submit

January 28, 2022

Conditions

Keywords

Multidimensional Voice DisorderVoice QualityOccupational Voice Users

Outcome Measures

Primary Outcomes (5)

  • F0 (Fundamental Frequency)

    Average fundamental frequency for the vocalization measured in Hz

    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.

    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

    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

    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.

    3 minutes minimal

Study Arms (2)

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

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)

Diagnostic Test: Multidimensional Voice Program

Interventions

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.

Also known as: Acoustic Phonation Program, Kay Elemetric Corp MDVP 4500
Non-occupational Voice UsersOccupational Voice Users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with incomplete occupational data
  • Patient with incomplete MDVP results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • Feder 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.

  • Godino-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.

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mikhael Yosia, MD

    Department of Community Medicine, Faculty of Medicine Universitas Indonesia

    PRINCIPAL INVESTIGATOR
  • Dewi S Soemarko, MD

    Department of Community Medicine, Faculty of Medicine Universitas Indonesia

    STUDY CHAIR
  • Marsen Isbayuputra, MD

    Department of Community Medicine, Faculty of Medicine Universitas Indonesia

    STUDY CHAIR
  • Syahrial M Hutauruk, MD

    Department of ORL-HNS, Faculty of Medicine Universitas Indonesia

    STUDY CHAIR

Central Study Contacts

Mikhael Yosia, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will be kept in Cipto Mangunkusumo General Hospital and will only be shared upon official request to the hospital.