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DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)

29. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

720

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: HUNG C F Kaohsiung Medical University, MASTER
  • Telefonnummer: #2646 #614 +8867-3121101
  • E-post: gabino00076@gmail.com

Studiesteder

  • Taiwan
    • Taiwan
      • Kaohsiung City, Taiwan, Taiwan, 807
        • Department of Sports Medicine, Kaohsiung Medical University, Taiwan
        • Ta kontakt med:
        • Ta kontakt med:
          • L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
          • Telefonnummer: #2646 #624 +8867-3121101
          • E-post: yuen@kmu.edu.tw
        • Underetterforsker:
          • C F HUNG, Master

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Repetitive Saliva Swallowing Test Classification
Tidsramme: Day 1
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.
Day 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Eating Assessment Tool-10 Total Score
Tidsramme: Day 1
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.
Day 1
Diadochokinetic Speech Rate
Tidsramme: Day 1
Rate of repeated diadochokinetic speech productions of /pa/, /ta/, and /ka/. The rate will be reported as syllables per second.
Day 1
Diadochokinetic Speech Fundamental Frequency
Tidsramme: Day 1
Fundamental frequency (F0) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/. Fundamental frequency will be reported in Hertz (Hz).
Day 1
Diadochokinetic Speech First Formant Frequency
Tidsramme: Day 1
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).
Day 1
Diadochokinetic Speech Second Formant Frequency
Tidsramme: Day 1
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).
Day 1
Diadochokinetic Speech Jitter
Tidsramme: Day 1
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.
Day 1
Diadochokinetic Speech Shimmer
Tidsramme: Day 1
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).
Day 1
Diadochokinetic Speech Harmonics-to-Noise Ratio
Tidsramme: Day 1
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).
Day 1
Diadochokinetic Speech Root Mean Square Amplitude
Tidsramme: Day 1
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.
Day 1
Diadochokinetic Speech Zero-Crossing Rate
Tidsramme: Day 1
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.
Day 1

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant Age
Tidsramme: Day 1
Age of participants collected at baseline, reported in years.
Day 1
Participant Sex
Tidsramme: Day 1
Sex of participants collected on Day 1, reported as male or female according to the study case report form.
Day 1
Education Level
Tidsramme: Day 1
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.
Day 1
Body Mass Index
Tidsramme: Day 1
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.
Day 1
Dentition Status
Tidsramme: Day 1
Dentition status of participants collected at day 1, categorized as natural dentition, partial denture, full denture, or other.
Day 1
Dry Mouth Frequency
Tidsramme: Day 1
Self-reported frequency of dry mouth symptoms collected at day 1, categorized as never, occasionally, frequently, or always.
Day 1
Smoking History
Tidsramme: Day 1
Self-reported smoking history collected at baseline, categorized as never smoker, former smoker, or current smoker.
Day 1
Medical History
Tidsramme: Day 1
Self-reported medical history collected at day 1 and categorized as none, hypertension, hyperglycemia, hyperlipidemia, or gastrointestinal disease (such as gastroesophageal reflux disease).
Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kaohsiung Medical University

Etterforskere

  • Studiestol: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

9. april 2030

Studiet fullført (Antatt)

9. april 2030

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KMUHIRB-F(II)-20260160 (Annen identifikator: IRB of KMUH)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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