- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07626749
DDK Acoustic Analysis and Swallowing Indicators (AAP-DDK)
2026년 5월 29일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
720
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: HUNG C F Kaohsiung Medical University, MASTER
- 전화번호: #2646 #614 +8867-3121101
- 이메일: gabino00076@gmail.com
연구 장소
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Taiwan
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Kaohsiung City, Taiwan, 대만, 807
- Department of Sports Medicine, Kaohsiung Medical University, Taiwan
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연락하다:
- C F HUNG, MASTER
- 전화번호: #2646 #624 +8867-3121101
- 이메일: gabino00076@gmail.com
-
연락하다:
- L Y GUO Professor and Dean of the college of Health Sciences, Doctorate
- 전화번호: #2646 #624 +8867-3121101
- 이메일: yuen@kmu.edu.tw
-
부수사관:
- C F HUNG, Master
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Repetitive Saliva Swallowing Test Classification
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eating Assessment Tool-10 Total Score
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant Age
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: GUO L Y Professor and Dean of the College of Health Sciences, Departme, Ph. D., Department of Sports Science, Kaohsiung Medical University, Taiwan
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2030년 4월 9일
연구 완료 (추정된)
2030년 4월 9일
연구 등록 날짜
최초 제출
2026년 5월 22일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KMUHIRB-F(II)-20260160 (기타 식별자: IRB of KMUH)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .