AI-Based Speech Intelligibility Assessment: Efficacy & Reliability

NCT07347782 | Not Yet Recruiting

• 1 other identifier: 11-2025-086
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare the auditory-perceptual assessment conducted by speech-language pathologists using the U-TAP with the assessment performed via the AI solution (Blings) program in patients with speech disorders, and to evaluate the efficacy and reliability of these two methods for speech intelligibility assessment.

Conditions

Patients With Speech Disorders

Outcome Measures

Primary Outcomes (1)

• Word-level consonant accuracy (%) derived from speech samples obtained during the U-TAP assessment

  The agreement between consonant accuracy analyzed by the AI-based speech disorder analysis program (Blings) and the evaluations conducted independently by two certified speech-language pathologists (Rater 1 and Rater 2). Consonant accuracy is calculated at the word level and expressed as a percentage score ranging from 0% to 100%. The mean value of consonant accuracy scores from Rater 1 and Rater 2 is used as the reference human evaluation.

  Visit 1 (Baseline)

Secondary Outcomes (3)

• Test-retest reliability of word-level consonant accuracy (%) calculated by Blings

  Visit 1 and Visit 2 (7 ± 5 days interval)

• Inter-rater agreement of word-level consonant accuracy (%) among Blings, Rater 1, and Rater 2

  Visit 1 and Visit 2 (7 ± 5 days interval)

• Time required to complete speech analysis (seconds)

  Visit 1 and Visit 2 (7 ± 5 days interval)

Study Arms (1)

Observational study(Patients with speech disorders)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years or older with neurologic disorders-including amyotrophic lateral sclerosis (ALS), poliomyelitis, cerebellar-related disorders (such as cerebellar atrophy or degeneration and cerebellar lesions), and stroke-who present with concomitant speech disorders, such as dysarthria, motor speech disorders, and voice disorders. Participants must have sufficient cognitive function, defined as a Korean Mini-Mental State Examination (K-MMSE) score of 16 or higher, and must be capable of understanding and following the examiner's instructions. Individuals with visual, perceptual, or auditory impairments that interfere with participation in speech assessment, as well as those deemed unsuitable for study participation by the investigator for other clinical or practical reasons, are excluded.

You may qualify if:

• Adults aged 18 years or older.
• Patients with neurologic disorders, including amyotrophic lateral sclerosis, poliomyelitis, cerebellar disorders, cerebellar lesions, and stroke.
• Patients presenting with concomitant speech disorders, such as dysarthria, motor speech disorders, and voice disorders.

You may not qualify if:

• Subjects with a score of less than 16 points on the Korean Mini-Mental State Examination (K-MMSE).
• Subjects with visual, perceptual, or auditory impairments that prevent them from following the examiner's instructions.
• Subjects judged by the researcher as unsuitable for participation in this clinical study due to other reasons.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Central Study Contacts

Jisoo Baik

CONTACT

082+055-360-4159; zisoo@pusan.ac.kr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01