Patients With Speech DisordersAI SolutionNCT07347782
AI-Based Speech Intelligibility Assessment: Efficacy & Reliability
An observational study of Patients With Speech Disorders, run by Pusan National University Yangsan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Speech Disorders
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Study on the Efficacy and Reliability of Speech Intelligibility Assessment for Post-stroke Patients Using an AI Solution
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational study(Patients with speech disorders) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (Baseline)
Secondary outcomes (3)
Test-retest reliability of word-level consonant accuracy (%) calculated by Blings
The consistency of consonant accuracy scores generated by Blings from the same participant across two visits. Comparison of Blings-derived consonant accuracy scores (%) between Visit 1 and Visit 2. Scores range from 0% to 100%.
Measured: Visit 1 and Visit 2 (7 ± 5 days interval)
Inter-rater agreement of word-level consonant accuracy (%) among Blings, Rater 1, and Rater 2
Agreement in consonant accuracy evaluations between the AI-based analysis and human raters. Pairwise comparisons: Rater 1 vs. Rater 2, Blings vs. Rater 1, Blings vs. Rater 2. Scores expressed as percentages (0-100%)
Measured: Visit 1 and Visit 2 (7 ± 5 days interval)
Time required to complete speech analysis (seconds)
Comparison of analysis time between the AI-based system (Blings) and human raters. Total analysis time measured in seconds for: Rater 1, Rater 2, Blings
Measured: Visit 1 and Visit 2 (7 ± 5 days interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Speech 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347782
- Sponsor's protocol ID
- 11-2025-086
- Acronym
- AI Solution
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Reliability of Speech Intelligibility Assessment for Post-stroke Patients Using an AI Solution
- ClinicalTrials.gov ID
- NCT07347782
- Acronym / sponsor ID
- AI Solution / 11-2025-086
- Conditions
- Patients With Speech Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jan 2026 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational study(Patients with speech disorders) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Word-level consonant accuracy (%) derived from speech samples obtained during the U-TAP assessment
Time frame: Visit 1 (Baseline)
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.
3 secondary outcomes
Test-retest reliability of word-level consonant accuracy (%) calculated by Blings
Time frame: Visit 1 and Visit 2 (7 ± 5 days interval)
Inter-rater agreement of word-level consonant accuracy (%) among Blings, Rater 1, and Rater 2
Time frame: Visit 1 and Visit 2 (7 ± 5 days interval)
Time required to complete speech analysis (seconds)
Time frame: Visit 1 and Visit 2 (7 ± 5 days interval)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Speech Disorders, run by Pusan National University Yangsan Hospital.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jisoo Baik (082+055-360-4159, zisoo@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word-level consonant accuracy (%) derived from speech samples obtained during the U-TAP assessment (time frame: Visit 1 (Baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2026.