Dysphagia Risk in Rheumatic Diseases

April 2, 2026 updated by: Sinem Bozcuk Gün, Pamukkale University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
191

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kınıklı
      • Denizli, Kınıklı, Turkey (Türkiye)
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

inflammatory rheumatic diseases

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
at baseline
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
at baseline
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.
at baseline
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.
at baseline
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.
at baseline
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.
at baseline
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.
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAU 2026 01 DYSPHAGIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are not available due to ethical and privacy restrictions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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