DysphagiaNCT07098767
SURE Trial: Swallowing Ultrasound Reliability Evaluation Trial
An observational study of Dysphagia and Swallowing Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study aims to explore the reliability of using ultrasonography (US) for the assessment of swallowing function in patients with dysphagia. The study will recruit 80 patients and compare the findings with those obtained from fiberoptic endoscopic evaluation of swallowing (FEES), which serves as the gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Swallowing Disorder
- What is being tested?
- ultrasound evaluation and Fiberoptic endoscopic evaluation of swallowing (FEES)
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2024to 31 Oct 2027
- 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
- Adult, Older adult
Study population: The study population includes adult patients aged 18 years and older who have been referred for dysphagia evaluation. Participants will have varying degrees of swallowing difficulty, stemming from conditions such as stroke, head and neck cancer, or neurodegenerative diseases. Eligible individuals will have a Functional Oral Intake Scale (FOIS) score between 2 and 6. The population will be recruited from both outpatient and inpatient settings within the rehabilitation department of National Taiwan University Hospital. Patients must be conscious and able to follow instructions, ensuring accurate participation in both ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES). Those with unstable vital signs, acute infections, mechanical ventilation, or cognitive impairments preventing effective participation will be excluded from the study.
Who may be able to join
- Adults aged 18 or older.
- Dysphagia patients referred for swallowing assessments.
- FOIS score between 2-6.
Who cannot join
- Unconscious patients or those unable to follow instructions.
- Unstable vital signs.
- Acute infections or mechanical ventilation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Shu-mei Yang, MD, 0972653675, b99401109@gmail.com
About this study
Official title: Investigating the Reliability of Using Ultrasonography to Assess Swallowing Function in Patients With Dysphagia
This study aims to explore the reliability of using ultrasonography (US) for the assessment of swallowing function in patients with dysphagia. The study will recruit 80 patients and compare the findings with those obtained from fiberoptic endoscopic evaluation of swallowing (FEES), which serves as the gold standard.
Read the detailed description
This study will evaluate the reliability of using ultrasonography as a non-invasive tool for assessing swallowing function in patients with dysphagia. Participants will undergo US and FEES assessments to examine vocal cord function, swallowing reflex, pharyngeal contraction, aspiration/penetration, and stasis. The reliability, diagnostic accuracy, and inter-/intra-rater reliability will be analyzed to validate US as an effective alternative in clinical dysphagia assessment.
- Conditions
- Dysphagia, Swallowing Disorder
- Being tested
- ultrasound evaluation, Fiberoptic endoscopic evaluation of swallowing (FEES)
- Keywords
- dysphagia, ultrasonography, swallowing assessment
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound evaluationDiagnostic test
Use high-frequency ultrasonography to assess the swallowing function in patients with dysphagia. The ultrasound examination focuses on visualization of the pharyngeal region to measure vocal cord movement, swallowing reflex, pharyngeal contraction, and the presence and location of pharyngeal residue.
Fiberoptic endoscopic evaluation of swallowing (FEES)Diagnostic test
FEES involves the use of a flexible endoscope inserted through the nasal passage to observe the pharyngeal phase of swallowing directly. This procedure allows for the real-time assessment of key aspects of swallowing, including vocal cord function, swallowing reflex, pharyngeal contraction, and the detection of aspiration or penetration.
| Study group | Role | What they receive |
|---|---|---|
| Dysphagia patients | This cohort consists of patients with dysphagia undergoing swallowing function assessments. Participants will undergo two types of assessments: ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES), to evaluate key parameters of swallowing function. Receives: Diagnostic Test: ultrasound evaluation; Diagnostic Test: Fiberoptic endoscopic evaluation of swallowing (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of Ultrasonography in Swallowing Function Assessment
Comparison with FEES findings
Measured: Immediate post-assessment.
Secondary outcomes (1)
Diagnostic Accuracy
Sensitivity, specificity, positive predictive value, and negative predictive value of US in detecting dysphagia.
Measured: Immediate post-assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Nov 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-mei Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098767
- Sponsor's protocol ID
- 202406013RINA
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsiao MY, Wu CH, Wang TG. Emerging Role of Ultrasound in Dysphagia Assessment and Intervention: A Narrative Review. Front Rehabil Sci. 2021 Aug 11;2:708102. doi: 10.3389/fresc.2021.708102. eCollection 2021.
PubMed 36188819Dunn CJ, Fitton A, Sorkin EM. Etidronic acid. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs Aging. 1994 Dec;5(6):446-74. doi: 10.2165/00002512-199405060-00006.
PubMed 7858370Allen JE, Clunie GM, Winiker K. Ultrasound: an emerging modality for the dysphagia assessment toolkit? Curr Opin Otolaryngol Head Neck Surg. 2021 Jun 1;29(3):213-218. doi: 10.1097/MOO.0000000000000708.
PubMed 33741822
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Reliability of Using Ultrasonography to Assess Swallowing Function in Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT07098767
- Acronym / sponsor ID
- 202406013RINA
- Conditions
- Dysphagia, Swallowing Disorder
- Keywords
- dysphagia, ultrasonography, swallowing assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 1 Aug 2025 (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 aims to explore the reliability of using ultrasonography (US) for the assessment of swallowing function in patients with dysphagia. The study will recruit 80 patients and compare the findings with those obtained from fiberoptic endoscopic evaluation of swallowing (FEES), which serves as the gold standard.
Detailed description
This study will evaluate the reliability of using ultrasonography as a non-invasive tool for assessing swallowing function in patients with dysphagia. Participants will undergo US and FEES assessments to examine vocal cord function, swallowing reflex, pharyngeal contraction, aspiration/penetration, and stasis. The reliability, diagnostic accuracy, and inter-/intra-rater reliability will be analyzed to validate US as an effective alternative in clinical dysphagia assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysphagia patients | – | Diagnostic Test: ultrasound evaluation, Diagnostic Test: Fiberoptic endoscopic evaluation of swallowing (FEES)This cohort consists of patients with dysphagia undergoing swallowing function assessments. Participants will undergo two types of assessments: ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES), to evaluate key parameters of swallowing function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients aged 18 years and older who have been referred for dysphagia evaluation. Participants will have varying degrees of swallowing difficulty, stemming from conditions such as stroke, head and neck cancer, or neurodegenerative diseases. Eligible individuals will have a Functional Oral Intake Scale (FOIS) score between 2 and 6. The population will be recruited from both outpatient and inpatient settings within the rehabilitation department of National Taiwan University Hospital. Patients must be conscious and able to follow instructions, ensuring accurate participation in both ultrasonography and fiberoptic endoscopic evaluation of swallowing (FEES). Those with unstable vital signs, acute infections, mechanical ventilation, or cognitive impairments preventing effective participation will be excluded from the study.
Key inclusion criteria (3 listed)
- Adults aged 18 or older.
- Dysphagia patients referred for swallowing assessments.
- FOIS score between 2-6.
Key exclusion criteria (3 listed)
- Unconscious patients or those unable to follow instructions.
- Unstable vital signs.
- Acute infections or mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound evaluationUse high-frequency ultrasonography to assess the swallowing function in patients with dysphagia. The ultrasound examination focuses on visualization of the pharyngeal region to measure vocal cord movement, swallowing reflex, pharyngeal contraction, and the presence and location of pharyngeal residue. | Diagnostic test | Dysphagia patients |
| Fiberoptic endoscopic evaluation of swallowing (FEES)FEES involves the use of a flexible endoscope inserted through the nasal passage to observe the pharyngeal phase of swallowing directly. This procedure allows for the real-time assessment of key aspects of swallowing, including vocal cord function, swallowing reflex, pharyngeal contraction, and the detection of aspiration or penetration. | Diagnostic test | Dysphagia patients |
Primary outcome
Reliability of Ultrasonography in Swallowing Function Assessment
Time frame: Immediate post-assessment.
Comparison with FEES findings
1 secondary outcome
Diagnostic Accuracy
Time frame: Immediate post-assessment.
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 1 Aug 2025.
- Background: PubMed 36188819Hsiao MY, Wu CH, Wang TG. Emerging Role of Ultrasound in Dysphagia Assessment and Intervention: A Narrative Review. Front Rehabil Sci. 2021 Aug 11;2:708102. doi: 10.3389/fresc.2021.708102. eCollection 2021.
- Background: PubMed 7858370Dunn CJ, Fitton A, Sorkin EM. Etidronic acid. A review of its pharmacological properties and therapeutic efficacy in resorptive bone disease. Drugs Aging. 1994 Dec;5(6):446-74. doi: 10.2165/00002512-199405060-00006.
- Background: PubMed 33741822Allen JE, Clunie GM, Winiker K. Ultrasound: an emerging modality for the dysphagia assessment toolkit? Curr Opin Otolaryngol Head Neck Surg. 2021 Jun 1;29(3):213-218. doi: 10.1097/MOO.0000000000000708.
- Individual participant dataSharing planned: No
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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.
Shu-mei Yang, MD principal investigator
National Taiwan University Hospital
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 Dysphagia and Swallowing Disorder, run by National Taiwan University Hospital 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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 Shu-mei Yang, MD (0972653675, b99401109@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of Ultrasonography in Swallowing Function Assessment (time frame: Immediate post-assessment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07098767, which also lists 3 linked publications.
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 1 Aug 2025.