DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)
29 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Descrição detalhada
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 estudo
Observacional
Inscrição (Estimado)
720
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: HUNG C F Kaohsiung Medical University, MASTER
- Número de telefone: #2646 #614 +8867-3121101
- E-mail: gabino00076@gmail.com
Locais de estudo
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Taiwan
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Kaohsiung City, Taiwan, Taiwan, 807
- Department of Sports Medicine, Kaohsiung Medical University, Taiwan
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Contato:
- C F HUNG, MASTER
- Número de telefone: #2646 #624 +8867-3121101
- E-mail: gabino00076@gmail.com
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Contato:
- L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
- Número de telefone: #2646 #624 +8867-3121101
- E-mail: yuen@kmu.edu.tw
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Subinvestigador:
- C F HUNG, Master
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Repetitive Saliva Swallowing Test Classification
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Eating Assessment Tool-10 Total Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant Age
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de junho de 2026
Conclusão Primária (Estimado)
9 de abril de 2030
Conclusão do estudo (Estimado)
9 de abril de 2030
Datas de inscrição no estudo
Enviado pela primeira vez
22 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KMUHIRB-F(II)-20260160 (Outro identificador: IRB of KMUH)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .