Inflammatory Rheumatic DiseasesNCT07504900
Dysphagia Risk in Rheumatic Diseases
An observational study of Inflammatory Rheumatic Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Rheumatic Diseases
- How many people
- 191 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: inflammatory rheumatic diseases
Who may be able to join
- Having a diagnosis of a rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, etc.)
- Being 18 years of age or older
- Having the cognitive ability to answer the questionnaires
- Volunteering to participate in the study
Who cannot join
- Having any neurological or psychological disorder that may prevent participation
- Having a psychiatric disorder severe enough to affect cooperation
- Being hospitalized during an acute flare
- History of active gastrointestinal surgery within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Dysphagia Risk in Individuals With Inflammatory Rheumatic Diseases
This study aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia.
- Conditions
- Inflammatory Rheumatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Assessment Tool (EAT-10)
The primary outcome is the risk of dysphagia in patients with inflammatory rheumatic diseases, measured using a validated questionnaire administered once to each participant. The swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The scale consists of 10 items, with a total score ranging from 0 to 40. Higher scores indicate a greater severity of swallowing impairment (a score of ≥3 is considered indicative of dysphagia)
Measured: at baseline
Fonseca Anamnestic Questionnaire
The severity of temporomandibular disorders was assessed using the Fonseca Anamnestic Index (FAI). The index consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate a greater severity of temporomandibular dysfunction
Measured: at baseline
Gastrointestinal Symptom Rating Scale (GSRS)
Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items scored on a 7-point Likert scale ranging from 1 to 7. Total and subscale scores are calculated, where higher scores indicate greater symptom severity and a worse clinical condition.
Measured: at baseline
Functional Oral Intake Scale (FOIS)
The patient's functional level of oral intake was assessed using the Functional Oral Intake Scale (FOIS). The scale is a 7-point ordinal scale with scores ranging from 1 to 7. Unlike many other clinical tools, higher scores on the FOIS indicate better functional oral intake, with a score of 1 representing total tube dependency and a score of 7 representing total oral intake with no restrictions.
Measured: at baseline
Mediterranean Diet Quality Index (KIDMED)
Nutritional habits and adherence to the Mediterranean diet were evaluated using the Mediterranean Diet Quality Index (KIDMED). The index is based on a 16-item questionnaire with total scores ranging from -4 to 12. Higher scores indicate better adherence to the Mediterranean diet and higher dietary quality.
Measured: at baseline
Reflux Symptom Index (RSI)
The severity of laryngopharyngeal reflux symptoms was assessed using the Reflux Symptom Index (RSI). The index is a 9-item self-reported questionnaire with a total score ranging from 0 to 45. Higher scores indicate a greater severity of symptoms, with a score of 13 or higher typically considered as clinically significant for reflux.
Measured: at baseline
Malnutrition Inflammation Score
Nutritional status and inflammation levels were assessed using the Malnutrition-Inflammation Score (MIS). The score consists of 10 components, including clinical history, physical examination, body mass index, and laboratory parameters (serum albumin and total iron-binding capacity). Each component is scored from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate a greater severity of malnutrition and inflammation.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start15 Sep 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Rheumatic DiseasesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Bozcuk Gün, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504900
- Sponsor's protocol ID
- PAU 2026 01 DYSPHAGIA
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are not available due to ethical and privacy restrictions
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dysphagia Risk in Individuals With Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT07504900
- Acronym / sponsor ID
- PAU 2026 01 DYSPHAGIA
- Conditions
- Inflammatory Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 191 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 1 Apr 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 aims to evaluate the impact of dysphagia on eating and swallowing functions, gastrointestinal symptoms, and related clinical findings in individuals with inflammatory rheumatic diseases. Additionally, the study aims to identify differences between individuals with and without dysphagia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- inflammatory rheumatic diseases
Key inclusion criteria (4 listed)
- Having a diagnosis of a rheumatic disease (e.g., rheumatoid arthritis, ankylosing spondylitis, etc.)
- Being 18 years of age or older
- Having the cognitive ability to answer the questionnaires
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- Having any neurological or psychological disorder that may prevent participation
- Having a psychiatric disorder severe enough to affect cooperation
- Being hospitalized during an acute flare
- History of active gastrointestinal surgery within the last 3 months
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
Eating Assessment Tool (EAT-10)
Time frame: at baseline
The primary outcome is the risk of dysphagia in patients with inflammatory rheumatic diseases, measured using a validated questionnaire administered once to each participant. The swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The scale consists of 10 items, with a total score ranging from 0 to 40. Higher scores indicate a greater severity of swallowing impairment (a score of ≥3 is considered indicative of dysphagia)
Fonseca Anamnestic Questionnaire
Time frame: at baseline
The severity of temporomandibular disorders was assessed using the Fonseca Anamnestic Index (FAI). The index consists of 10 items with a total score ranging from 0 to 100. Higher scores indicate a greater severity of temporomandibular dysfunction
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: at baseline
Gastrointestinal symptoms were evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The scale consists of 15 items scored on a 7-point Likert scale ranging from 1 to 7. Total and subscale scores are calculated, where higher scores indicate greater symptom severity and a worse clinical condition.
Functional Oral Intake Scale (FOIS)
Time frame: at baseline
The patient's functional level of oral intake was assessed using the Functional Oral Intake Scale (FOIS). The scale is a 7-point ordinal scale with scores ranging from 1 to 7. Unlike many other clinical tools, higher scores on the FOIS indicate better functional oral intake, with a score of 1 representing total tube dependency and a score of 7 representing total oral intake with no restrictions.
Mediterranean Diet Quality Index (KIDMED)
Time frame: at baseline
Nutritional habits and adherence to the Mediterranean diet were evaluated using the Mediterranean Diet Quality Index (KIDMED). The index is based on a 16-item questionnaire with total scores ranging from -4 to 12. Higher scores indicate better adherence to the Mediterranean diet and higher dietary quality.
Reflux Symptom Index (RSI)
Time frame: at baseline
The severity of laryngopharyngeal reflux symptoms was assessed using the Reflux Symptom Index (RSI). The index is a 9-item self-reported questionnaire with a total score ranging from 0 to 45. Higher scores indicate a greater severity of symptoms, with a score of 13 or higher typically considered as clinically significant for reflux.
Malnutrition Inflammation Score
Time frame: at baseline
Nutritional status and inflammation levels were assessed using the Malnutrition-Inflammation Score (MIS). The score consists of 10 components, including clinical history, physical examination, body mass index, and laboratory parameters (serum albumin and total iron-binding capacity). Each component is scored from 0 to 3, with total scores ranging from 0 to 30. Higher scores indicate a greater severity of malnutrition and inflammation.
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 8 Apr 2026.
- Individual participant dataSharing planned: No. Data are not available due to ethical and privacy restrictions
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Rheumatic Diseases, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Assessment Tool (EAT-10) (time frame: at baseline). The study lists 7 primary outcomes in all. 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 8 Apr 2026.