DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)
29. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
720
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: HUNG C F Kaohsiung Medical University, MASTER
- Telefonnummer: #2646 #614 +8867-3121101
- E-Mail: gabino00076@gmail.com
Studienorte
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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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Kontakt:
- C F HUNG, MASTER
- Telefonnummer: #2646 #624 +8867-3121101
- E-Mail: gabino00076@gmail.com
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Kontakt:
- L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
- Telefonnummer: #2646 #624 +8867-3121101
- E-Mail: yuen@kmu.edu.tw
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Unterermittler:
- C F HUNG, Master
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Repetitive Saliva Swallowing Test Classification
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Eating Assessment Tool-10 Total Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Participant Age
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. Juni 2026
Primärer Abschluss (Geschätzt)
9. April 2030
Studienabschluss (Geschätzt)
9. April 2030
Studienanmeldedaten
Zuerst eingereicht
22. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
4. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KMUHIRB-F(II)-20260160 (Andere Kennung: IRB of KMUH)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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