DDK Acoustic Analysis and Swallowing Indicators

NCT07626749 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(II)-20260160
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

Brief 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. The study is non-invasive, takes about 75 minutes, and may help develop an easy, low-cost screening tool for early swallowing problems.

Conditions

Swallowing Risk; Swallowing Function; Dysphagia

Keywords

Dysphagia; Swallowing Function; diadochokinetic; Acoustic Analysis; Repetitive Saliva Swallowing Test; EAT-10; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (10)

• Eating Assessment Tool-10 Total Score

  Day 1

• Diadochokinetic Speech Rate

  Day 1

• Diadochokinetic Speech Fundamental Frequency

  Day 1

• Diadochokinetic Speech First Formant Frequency

  Day 1

• Diadochokinetic Speech Second Formant Frequency

  Day 1

Other Outcomes (8)

• Participant Age

  Day 1

• Participant Sex

  Day 1

• Education Level

  Day 1

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Community-dwelling adults aged 18 years or older, with no upper age limit.
• Ability to communicate in Mandarin or Taiwanese and understand the study procedures.
• Willingness to provide written informed consent.
• Ability to complete the DDK tasks and RSST.

You may not qualify if:

• Presence of acute respiratory infection, upper respiratory inflammation, or other acute conditions that may significantly affect speech or swallowing.
• Impaired consciousness, significant cognitive deficits, or inability to understand the study procedures.
• Recent surgery or radiotherapy involving the oral cavity or pharynx that affects speech or swallowing.
• Severe hearing impairment that prevents understanding of instructions.
• Any other condition deemed unsuitable for participation by the investigators.

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Department of Sports Medicine, Kaohsiung Medical University, Taiwan

Kaohsiung City, Taiwan, 807, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D.

  Department of Sports Science, Kaohsiung Medical University, Taiwan

  STUDY CHAIR

Central Study Contacts

HUNG C F Kaohsiung Medical University, MASTER

CONTACT

+8867-3121101; gabino00076@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): April 9, 2030
• Study Completion (Estimated): April 9, 2030
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

TW (1)