DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)
29 de mayo de 2026 actualizado por: Chen-Fu Hung, Kaohsiung Medical University
Acoustic Analysis of Performance in Diadochokinetic (DDK) Tasks and Swallowing Function Indicators Among Adults Across Different Age Groups
This study examines whether simple speech tasks and a swallowing screening test can help identify swallowing risk in adults of different ages.
Participants will complete basic questions, a swallowing self-assessment, a saliva swallowing test, and short voice recordings of rapid syllables.
The study is non-invasive, takes about 75 minutes, and may help develop an easy, low-cost screening tool for early swallowing problems.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
This is a cross-sectional observational study examining the relationship between diadochokinetic (DDK) speech performance and swallowing function in community-dwelling adults aged 18 years and older.
Participants will complete a single study visit, during which demographic and health-related information will be collected, the EAT-10 swallowing self-assessment will be administered, the Repetitive Saliva Swallowing Test (RSST) will be performed, and short DDK speech recordings of /pa/, /ta/, and /ka/ will be obtained in a quiet setting.
Acoustic features will be extracted from the recordings and analyzed together with RSST and EAT-10 results to explore age-related differences and to develop a predictive screening model for swallowing risk.
All data will be de-identified, securely stored, and retained according to study requirements.
Tipo de estudio
De observación
Inscripción (Estimado)
720
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: HUNG C F Kaohsiung Medical University, MASTER
- Número de teléfono: #2646 #614 +8867-3121101
- Correo electrónico: gabino00076@gmail.com
Ubicaciones de estudio
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Taiwan
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Kaohsiung City, Taiwan, Taiwán, 807
- Department of Sports Medicine, Kaohsiung Medical University, Taiwan
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Contacto:
- C F HUNG, MASTER
- Número de teléfono: #2646 #624 +8867-3121101
- Correo electrónico: gabino00076@gmail.com
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Contacto:
- L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
- Número de teléfono: #2646 #624 +8867-3121101
- Correo electrónico: yuen@kmu.edu.tw
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Sub-Investigador:
- C F HUNG, Master
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of community-dwelling adults aged 18 years and older, with no upper age limit, who are able to communicate in Mandarin or Taiwanese, provide informed consent, and complete DDK tasks, RSST, and EAT-10 assessment.
Participants will be recruited from community organizations and related settings in the Kaohsiung-Pingtung region.
The study uses a single-visit observational design with age-based subgroup analyses and no intervention.
Descripción
Inclusion Criteria:
- 1.Community-dwelling adults aged 18 years or older, with no upper age limit.
- 2.Ability to communicate in Mandarin or Taiwanese and understand the study procedures.
- 3.Willingness to provide written informed consent.
- 4 .Ability to complete the DDK tasks and RSST.
Exclusion Criteria:
- 1.Presence of acute respiratory infection, upper respiratory inflammation, or other acute conditions that may significantly affect speech or swallowing.
- 2.Impaired consciousness, significant cognitive deficits, or inability to understand the study procedures.
- 3.Recent surgery or radiotherapy involving the oral cavity or pharynx that affects speech or swallowing.
- 4.Severe hearing impairment that prevents understanding of instructions.
- 5.Any other condition deemed unsuitable for participation by the investigators.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Age-Based Cohort
Community-dwelling adults aged 18 years and older who complete a single study visit including demographic questionnaire, EAT-10, RSST, and DDK speech recordings.
This is an observational cohort with no intervention, and data will be analyzed by age group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Repetitive Saliva Swallowing Test Classification
Periodo de tiempo: Day 1
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Classification of swallowing function based on the Repetitive Saliva Swallowing Test (RSST).
Participants will be classified as having normal RSST performance if they complete greater than or equal to 3 swallows in 30 seconds, and abnormal RSST performance if they complete fewer than 3 swallows in 30 seconds.
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Eating Assessment Tool-10 Total Score
Periodo de tiempo: Day 1
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Total score on the Eating Assessment Tool-10 (EAT-10), a 10-item self-report questionnaire used to assess swallowing-related symptoms.
The total score ranges from 0 to 40, where higher scores indicate worse swallowing-related symptoms.
A score of 3 or higher suggests possible swallowing difficulty.
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Day 1
|
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Diadochokinetic Speech Rate
Periodo de tiempo: Day 1
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Rate of repeated diadochokinetic speech productions of /pa/, /ta/, and /ka/.
The rate will be reported as syllables per second.
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Day 1
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Diadochokinetic Speech Fundamental Frequency
Periodo de tiempo: Day 1
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Fundamental frequency (F0) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
Fundamental frequency will be reported in Hertz (Hz).
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Day 1
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Diadochokinetic Speech First Formant Frequency
Periodo de tiempo: Day 1
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First formant frequency (F1) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
F1 reflects the first resonance frequency of the vocal tract and will be reported in Hertz (Hz).
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Day 1
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Diadochokinetic Speech Second Formant Frequency
Periodo de tiempo: Day 1
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Second formant frequency (F2) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
F2 reflects the second resonance frequency of the vocal tract and will be reported in Hertz (Hz).
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Day 1
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Diadochokinetic Speech Jitter
Periodo de tiempo: Day 1
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Jitter extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
Jitter reflects short-term cycle-to-cycle variability in fundamental frequency and will be reported as a percentage.
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Day 1
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Diadochokinetic Speech Shimmer
Periodo de tiempo: Day 1
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Shimmer extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
Shimmer reflects short-term variability in voice amplitude and will be reported in decibels (dB).
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Day 1
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Diadochokinetic Speech Harmonics-to-Noise Ratio
Periodo de tiempo: Day 1
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Harmonics-to-noise ratio (HNR) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
HNR reflects the ratio of periodic harmonic energy to noise energy in the voice signal and will be reported in decibels (dB).
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Day 1
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Diadochokinetic Speech Root Mean Square Amplitude
Periodo de tiempo: Day 1
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Root mean square (RMS) amplitude extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
RMS amplitude reflects the average acoustic energy of the speech signal and will be reported in normalized amplitude units.
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Day 1
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Diadochokinetic Speech Zero-Crossing Rate
Periodo de tiempo: Day 1
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Zero-crossing rate (ZCR) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/.
ZCR reflects the rate at which the speech signal changes sign over time and will be reported as the number of zero crossings per second.
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Day 1
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant Age
Periodo de tiempo: Day 1
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Age of participants collected at baseline, reported in years.
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Day 1
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Participant Sex
Periodo de tiempo: Day 1
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Sex of participants collected on Day 1, reported as male or female according to the study case report form.
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Day 1
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Education Level
Periodo de tiempo: Day 1
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Highest level of education completed by participants collected at baseline, categorized as primary school or below, junior high school, senior high school, or college or above.
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Day 1
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Body Mass Index
Periodo de tiempo: Day 1
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Body mass index (BMI) calculated from measured height and weight at baseline.
Height will be measured in meters and weight in kilograms; BMI will be reported in kg/m².
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Day 1
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Dentition Status
Periodo de tiempo: Day 1
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Dentition status of participants collected at day 1, categorized as natural dentition, partial denture, full denture, or other.
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Day 1
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Dry Mouth Frequency
Periodo de tiempo: Day 1
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Self-reported frequency of dry mouth symptoms collected at day 1, categorized as never, occasionally, frequently, or always.
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Day 1
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Smoking History
Periodo de tiempo: Day 1
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Self-reported smoking history collected at baseline, categorized as never smoker, former smoker, or current smoker.
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Day 1
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Medical History
Periodo de tiempo: Day 1
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Self-reported medical history collected at day 1 and categorized as none, hypertension, hyperglycemia, hyperlipidemia, or gastrointestinal disease (such as gastroesophageal reflux disease).
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Day 1
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
9 de abril de 2030
Finalización del estudio (Estimado)
9 de abril de 2030
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KMUHIRB-F(II)-20260160 (Otro identificador: IRB of KMUH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data collected during the trial, including baseline characteristics, intervention-related measures, and outcome data, will be shared with a data dictionary.
Marco de tiempo para compartir IPD
De-identified individual participant data (IPD) and supporting information will be available starting 2 years after publication of the primary study results and will remain accessible for 5 years.
Criterios de acceso compartido de IPD
De-identified individual participant data and related supporting documents will be made available only to qualified researchers affiliated with academic institutions, medical organizations, or public health agencies.
Requesters must submit a detailed research proposal and evidence of ethical approval.
Access will be granted subject to approval by the study team.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .