Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationNCT05634980
Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function
An observational study of Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization
- What is being tested?
- FEES
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a swallowing disorder
Who may be able to join
- Patients aged 20 years or older with a swallowing disorder on the Functional Oral Intake Scale (FOIS) of 1-6.
Who cannot join
- Unconscious, unable to communicate via gestures or words and cooperate with commands.
- Acutely infected or requiring respirator use.
- The oropharyngeal structure is abnormal and cannot be examined by endoscopy.
- Presence of tracheostomy tube
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ming-Yen Hsiao, +886-2-23123456 ext. 67316, myferrant@gmail.com
About this study
Official title: The Application of Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function in Dysphagia Patients
Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. However, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. Recently, International Dysphagia Diet Standardization Initiative (IDDSI) has provided a universal standard of food consistency. The present study aims to evaluate the accuracy of clinical swallowing evaluation using IDDSI standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.
- Being tested
- FEES
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEESOther
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) exam
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration aspiration scale (PAS)
Penetration aspiration scale
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 posted2 Dec 2022
- Study start3 Aug 2021
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet StandardizationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634980
- Sponsor's protocol ID
- 202105007RINB
- Status last verified
- Nov 2022
- First submitted
- 22 Nov 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Standardized Dysphagia Diet in Clinical Evaluation of Swallowing Function in Dysphagia Patients
- ClinicalTrials.gov ID
- NCT05634980
- Acronym / sponsor ID
- 202105007RINB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 2 Dec 2022 (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.
Diet modification has been a vital component in the management of dysphagia. The lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. However, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. Recently, International Dysphagia Diet Standardization Initiative (IDDSI) has provided a universal standard of food consistency. The present study aims to evaluate the accuracy of clinical swallowing evaluation using IDDSI standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a swallowing disorder
Key inclusion criteria (1 listed)
- Patients aged 20 years or older with a swallowing disorder on the Functional Oral Intake Scale (FOIS) of 1-6.
Key exclusion criteria (4 listed)
- Unconscious, unable to communicate via gestures or words and cooperate with commands.
- Acutely infected or requiring respirator use.
- The oropharyngeal structure is abnormal and cannot be examined by endoscopy.
- Presence of tracheostomy tube
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 |
|---|---|---|
| FEESFiberoptic Endoscopic Evaluation of Swallowing (FEES) exam | Other | – |
Primary outcome
Penetration aspiration scale (PAS)
Time frame: Day 1
Penetration aspiration scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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. This study is not recruiting at the moment.
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, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization, 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen Hsiao (+886223123456 ext. 67316, myferrant@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration aspiration scale (PAS) (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 2 Dec 2022.