Prospective study on diagnosis of hoarseness by acoustic measurement

A Prospective Observational Study on the Diagnostic Accuracy of the Acoustic Roughness Index (ARI) for Perceptual Roughness - A Prospective Observational Study on the Diagnostic Accuracy of ARI for Perceptual Roughness

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055118

Enrollment

400

Registered

2024-08-15

Start date

2024-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with voice disorders presenting with hoarseness

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
Calculation of Minimal Important Difference (MID) and Minimal Detectable Change (MDC) for AVQI, ABI and ARI	—

Countries

Japan

Contacts

Public ContactKiyohito Hosokawa

The University of Osaka Graduate School of Medicine Department of Otorhinolaryngology - Head and Neck Surgery

khosokawa@ent.med.osaka-u.ac.jp06-6879-3951

Outcome results