Swallowing FunctionAAP-DDKNCT07626749
DDK Acoustic Analysis and Swallowing Indicators
An observational study of Swallowing Function and Swallowing Risk, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Swallowing Function, Swallowing Risk, Dysphagia
- How many people
- 720 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2026to 9 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HUNG C F Kaohsiung Medical University, MASTER contact
Taiwan1 site
Department of Sports Medicine, Kaohsiung Medical University, Taiwan
Kaohsiung City, Taiwan, 807
C F HUNG, MASTER, +8867-3121101 ext. #2646 #624, gabino00076@gmail.com
L Y GUO Professor and Dean of the college of Health Sciences, Doctorate, +8867-3121101 ext. #2646 #624, yuen@kmu.edu.tw
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Swallowing Function, Swallowing Risk, Dysphagia
- Keywords
- Dysphagia, Swallowing Function, diadochokinetic, Acoustic Analysis, Repetitive Saliva Swallowing Test, EAT-10, Older Adults
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitive Saliva Swallowing Test Classification
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.
Measured: Day 1
Secondary outcomes (10)
Eating Assessment Tool-10 Total Score
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.
Measured: Day 1
Diadochokinetic Speech Rate
Rate of repeated diadochokinetic speech productions of /pa/, /ta/, and /ka/. The rate will be reported as syllables per second.
Measured: Day 1
Diadochokinetic Speech Fundamental Frequency
Fundamental frequency (F0) extracted from repeated diadochokinetic (DDK) speech recordings of /pa/, /ta/, and /ka/. Fundamental frequency will be reported in Hertz (Hz).
Measured: Day 1
Diadochokinetic Speech First Formant Frequency
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).
Measured: Day 1
Diadochokinetic Speech Second Formant Frequency
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).
Measured: Day 1
Diadochokinetic Speech Jitter
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.
Measured: Day 1
Diadochokinetic Speech Shimmer
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).
Measured: Day 1
Diadochokinetic Speech Harmonics-to-Noise Ratio
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).
Measured: Day 1
Diadochokinetic Speech Root Mean Square Amplitude
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.
Measured: Day 1
Diadochokinetic Speech Zero-Crossing Rate
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion9 Apr 2030 (estimated)
- Study completion9 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Fu Hung, Kaohsiung Medical University
- Investigators
- GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Study chair, Department of Sports Science, Kaohsiung Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626749
- Sponsor's protocol ID
- KMUHIRB-F(II)-20260160
- Other IDs
- KMUHIRB-F(II)-20260160
- Acronym
- AAP-DDK
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Analysis of Performance in Diadochokinetic (DDK) Tasks and Swallowing Function Indicators Among Adults Across Different Age Groups
- ClinicalTrials.gov ID
- NCT07626749
- Acronym / sponsor ID
- AAP-DDK / KMUHIRB-F(II)-20260160
- Conditions
- Swallowing Function, Swallowing Risk, Dysphagia
- Keywords
- Dysphagia, Swallowing Function, diadochokinetic, Acoustic Analysis, Repetitive Saliva Swallowing Test, EAT-10, Older Adults
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 9 Apr 2030 (estimated)
- Study completion
- 9 Apr 2030 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Repetitive Saliva Swallowing Test Classification
Time frame: 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.
10 secondary outcomes
Eating Assessment Tool-10 Total Score
Time frame: Day 1
Diadochokinetic Speech Rate
Time frame: Day 1
Diadochokinetic Speech Fundamental Frequency
Time frame: Day 1
Diadochokinetic Speech First Formant Frequency
Time frame: Day 1
Diadochokinetic Speech Second Formant Frequency
Time frame: Day 1
Diadochokinetic Speech Jitter
Time frame: Day 1
Diadochokinetic Speech Shimmer
Time frame: Day 1
Diadochokinetic Speech Harmonics-to-Noise Ratio
Time frame: Day 1
Diadochokinetic Speech Root Mean Square Amplitude
Time frame: Day 1
Diadochokinetic Speech Zero-Crossing Rate
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HUNG C F Kaohsiung Medical University, MASTER contact
GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D. study chair
Department of Sports Science, Kaohsiung Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swallowing Function and Swallowing Risk, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUNG C F Kaohsiung Medical University, MASTER (+8867-3121101 ext. #2646 #614, gabino00076@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitive Saliva Swallowing Test Classification (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.