DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)
29 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Stimato)
720
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: HUNG C F Kaohsiung Medical University, MASTER
- Numero di telefono: #2646 #614 +8867-3121101
- Email: gabino00076@gmail.com
Luoghi di studio
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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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Contatto:
- C F HUNG, MASTER
- Numero di telefono: #2646 #624 +8867-3121101
- Email: gabino00076@gmail.com
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Contatto:
- L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
- Numero di telefono: #2646 #624 +8867-3121101
- Email: yuen@kmu.edu.tw
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Sub-investigatore:
- C F HUNG, Master
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Repetitive Saliva Swallowing Test Classification
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Eating Assessment Tool-10 Total Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Participant Age
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 giugno 2026
Completamento primario (Stimato)
9 aprile 2030
Completamento dello studio (Stimato)
9 aprile 2030
Date di iscrizione allo studio
Primo inviato
22 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 maggio 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KMUHIRB-F(II)-20260160 (Altro identificatore: IRB of KMUH)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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 di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .