UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055118 |
|---|---|
| Receipt number | R000062959 |
| Scientific Title | A Prospective Observational Study on the Diagnostic Accuracy of the Acoustic Roughness Index (ARI) for Perceptual Roughness |
| Date of disclosure of the study information | 2024/08/15 |
| Last modified on | 2025/06/17 09:10:18 |
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Basic information
Public title
Prospective study on diagnosis of hoarseness by acoustic measurement
Acronym
Prospective study on diagnosis of hoarseness by acoustic measurement
Scientific Title
A Prospective Observational Study on the Diagnostic Accuracy of the Acoustic Roughness Index (ARI) for Perceptual Roughness
Scientific Title:Acronym
A Prospective Observational Study on the Diagnostic Accuracy of ARI for Perceptual Roughness
Region
| Japan |
Condition
Condition
Patients with voice disorders presenting with hoarseness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hoarse voices can be classified into rough or breathy categories based on auditory-perceptual judgments. It is known that the primary cause of breathy voices is simply the insufficiency of vocal fold closure during vocalization. However, the mechanism causing rough voices is not defined by a single factor, as is the case with breathy voices. Rough voices are related to a combination of factors such as the irregular vibration patterns of the vocal cords or their surroundings, as well as the pitch of the voice. Therefore, there is no single characteristic of the voice waveform of rough voices, and no acoustic measures have been able to objectively evaluate them.
The ARI developed by our group incorporates parameters for subharmonics, which are not included in conventional indices, into a regression equation based on an existing database, dramatically improving diagnostic accuracy. This study aims to evaluate the generalizability of its high diagnostic accuracy.
Basic objectives2
Others
Basic objectives -Others
Diagnostic accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
or all samples registered in this study, an auditory-perceptual evaluation will be conducted to assess the degree of rough hoarseness on a scale of 0 to 3 (R score). Samples with an average R score of 0.5 or higher from three or more evaluators will be classified as having rough hoarseness, while those with lower scores will be classified as not having rough hoarseness. ROC analysis will be performed using ARI, and the diagnostic accuracy will be evaluated based on the AUC value from the ROC analysis.
Diagnostic Accuracy of ARI for Roughness
For all samples registered in this study, an auditory-perceptual judgment will be conducted to assess the degree of roughness on a scale of 0 to 3 (R score). Samples with an average R score of 0.5 or higher from three or more evaluators will be classified as having roughness, while those with lower scores will be classified as not having roughness. ROC analysis will be performed using ARI, and the diagnostic accuracy will be evaluated based on the AUC value from the ROC analysis.
Key secondary outcomes
Calculation of Minimal Important Difference (MID) and Minimal Detectable Change (MDC) for AVQI, ABI and ARI
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient must have hoarseness with an auditory-perceptual judgment of G1 or higher in conversational speech or sustained vowel utterance at the time of examination.
The patient must be at least 18 years of age at the time of consent.
Key exclusion criteria
Those whose first language is not Japanese.
Those who are unable to move to the recording room.
Other patients who are deemed inappropriate to participate in the study by the physician in charge.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kiyohito |
| Middle name | |
| Last name | Hosokawa |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka, Japan.
TEL
06-6879-3951
khosokawa@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyohito |
| Middle name | |
| Last name | Hosokawa |
Organization
The University of Osaka Graduate School of Medicine
Division name
Department of Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2, Yamadaoka, Suita-city, Osaka, Japan.
TEL
06-6879-3951
Homepage URL
khosokawa@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital
Address
2-15, Yamadaoka, Suita-city, Osaka, japan
Tel
06-6879-3951
khosokawa@ent.me.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cohort study
Method of recruitment: All patients who visited our facility between August 2024 and March 2027 and met the selection criteria.
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062959
