COVID-19NCT06135207
The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
An observational study of COVID-19 and Dysphagia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the correlation between COVID-19 and dysphagia in adults. The population of the study consisted of those who applied to Bezmialem University, Department of Otorhinolaryngology, Dysphagia Outpatient Clinic with the complaint of dysphagia. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2022to 23 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18, who applied to the dysphagia outpatient clinic.
Who may be able to join
- Older than 18 years of age
- Suffering from dysphagia
- Not having mental retardation
Who cannot join
- Patients who did not have swallowing difficulties
- Refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Eyüp, 34230
About this study
This study aims to investigate the correlation between COVID-19 and dysphagia in adults. The population of the study consisted of those who applied to Bezmialem University, Department of Otorhinolaryngology, Dysphagia Outpatient Clinic with the complaint of dysphagia. Patients older than 18 years of age, suffering from dysphagia and not having mental retardation were included in the study. Patients who did not have swallowing difficulties and refused to participate in the study were excluded.
Read the detailed description
Coronavirus Disease 2019 (COVID-19) is characterized by involvement in multiple tissues and organs throughout the body. Conditions related to COVID-19 itself or its treatment are known to be associated with swallowing function. Our study aimed to investigate the correlation between COVID-19 and dysphagia in adults who applied to our dysphagia outpatient clinic. Patients over the age of 18, who applied to the dysphagia outpatient clinic were included in our study. Patients' demographic and COVID-19 information were recorded. Swallowing impairment of the patients was evaluated with the fiberoptic endoscopic swallowing study (FEES). FEES was scored with the Penetration-Aspiration Scale (PAS). Eating Assessment Tool-10 (EAT-10) questionnaire was used to examine how the quality of life of the patients was affected by swallowing difficulties. Oral motor dysfunction (OMD) evaluation was performed by the clinician.
- Keywords
- COVID-19, Dysphagia, Flexible endoscopic swallowing study, Oral motor dysfunction
- Medical subject headings
- COVID-19, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Group | Patients with a history of COVID-19 infection and experiencing symptoms of dysphagia. | |
| Non-COVID-19 Group | Patients who do not have a history of COVID-19 infection but experience symptoms of dysphagia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexible Endoscopic Evaluation of Swallowing (FEES)
Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).
Measured: Three Months
The Penetration - Aspiration Scale
The results of FEES was scored by the Penetration-Aspiration Scale. The Penetration - Aspiration Scale is an 8-point scale during instrumental swallowing assessments such as the fiberoptic endoscopic swallow study, both indicating the localization of the airway leak and demonstrating the response to the assessment.
Measured: Three Months
Oral Motor Dysfunction (OMD)
Oral motor dysfunction (OMD) assessment of the patients was performed by physical examination of the oropharyngeal mechanism. Lips, tongue, palate, cheeks, teeth, jaw, larynx, and oral reflexes were evaluated with 26 items in terms of lifting, pressing, extending, retraction, approximation, rolling, lateralization, movement, coordination, speed, tone, and strength. A scale of 1-4 was used for scoring (1=within functional limits, 2=mild impairment, 3=moderate impairment, 4=severe impairment). The total score ranged from 26 to 104, with higher scores indicating greater degree of impairment. Only a score of 26 was considered normal within functional limits.
Measured: Three Months
Cranial Nerve Examination
Nervus trigeminus (V. cranial nerve), Nervus facialis (VII. cranial nerve), Nervus glossopharyngeus (IX. cranial nerve), Nervus vagus (X. cranial nerve) and Nervus hypoglossus (XII. cranial nerve) which are five cranial nerves involved in swallowing function were evaluated by the clinician.
Measured: Three Months
Eating Assessment Tool-10 (EAT-10)
The Eating Assessment Tool-10 (EAT-10) was used to examine how the quality of life of the patients was affected because of their difficulty in swallowing.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start27 Jun 2022
- Primary completion23 Oct 2022
- Study completion23 Oct 2022
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 COVID-19Studies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Can TÖRPÜ, Bezmialem Vakif University
- Investigators
- Gökhan C Törpü, BPT, Principal investigator, Bezmialem Vakif UniversityMüberra Tanrıverdi, PhD, Study director, Bezmialem Vakif UniversityNahide Öztoprak, BPT, Study chair, Bezmialem Vakif UniversityÖmer F Çalım, PhD, Study chair, Bezmialem Vakif UniversityOrhan Özturan, PhD, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135207
- Sponsor's protocol ID
- BezmialemVU-GCT-02
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vergara J, Lirani-Silva C, Brodsky MB, Miles A, Clave P, Nascimento W, Mourao LF. Potential Influence of Olfactory, Gustatory, and Pharyngolaryngeal Sensory Dysfunctions on Swallowing Physiology in COVID-19. Otolaryngol Head Neck Surg. 2021 Jun;164(6):1134-1135. doi: 10.1177/0194599820972680. Epub 2020 Nov 10.
PubMed 33167752Dziewas R, Warnecke T, Zurcher P, Schefold JC. Dysphagia in COVID-19 -multilevel damage to the swallowing network? Eur J Neurol. 2020 Sep;27(9):e46-e47. doi: 10.1111/ene.14367. Epub 2020 Jun 13. No abstract available.
PubMed 32460415Cheney DM, Siddiqui MT, Litts JK, Kuhn MA, Belafsky PC. The Ability of the 10-Item Eating Assessment Tool (EAT-10) to Predict Aspiration Risk in Persons With Dysphagia. Ann Otol Rhinol Laryngol. 2015 May;124(5):351-4. doi: 10.1177/0003489414558107. Epub 2014 Oct 30.
PubMed 25358607
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
- ClinicalTrials.gov ID
- NCT06135207
- Acronym / sponsor ID
- BezmialemVU-GCT-02
- Keywords
- COVID-19, Dysphagia, Flexible endoscopic swallowing study, Oral motor dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 23 Oct 2022 (actual)
- First posted
- 18 Nov 2023 (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 investigate the correlation between COVID-19 and dysphagia in adults. The population of the study consisted of those who applied to Bezmialem University, Department of Otorhinolaryngology, Dysphagia Outpatient Clinic with the complaint of dysphagia. Patients older than 18 years of age, suffering from dysphagia and not having mental retardation were included in the study. Patients who did not have swallowing difficulties and refused to participate in the study were excluded.
Detailed description
Coronavirus Disease 2019 (COVID-19) is characterized by involvement in multiple tissues and organs throughout the body. Conditions related to COVID-19 itself or its treatment are known to be associated with swallowing function. Our study aimed to investigate the correlation between COVID-19 and dysphagia in adults who applied to our dysphagia outpatient clinic. Patients over the age of 18, who applied to the dysphagia outpatient clinic were included in our study. Patients' demographic and COVID-19 information were recorded. Swallowing impairment of the patients was evaluated with the fiberoptic endoscopic swallowing study (FEES). FEES was scored with the Penetration-Aspiration Scale (PAS). Eating Assessment Tool-10 (EAT-10) questionnaire was used to examine how the quality of life of the patients was affected by swallowing difficulties. Oral motor dysfunction (OMD) evaluation was performed by the clinician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Group | – | –Patients with a history of COVID-19 infection and experiencing symptoms of dysphagia. |
| Non-COVID-19 Group | – | –Patients who do not have a history of COVID-19 infection but experience symptoms of dysphagia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18, who applied to the dysphagia outpatient clinic.
Key inclusion criteria (3 listed)
- Older than 18 years of age
- Suffering from dysphagia
- Not having mental retardation
Key exclusion criteria (2 listed)
- Patients who did not have swallowing difficulties
- Refused to participate in the study
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
Flexible Endoscopic Evaluation of Swallowing (FEES)
Time frame: Three Months
Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).
The Penetration - Aspiration Scale
Time frame: Three Months
The results of FEES was scored by the Penetration-Aspiration Scale. The Penetration - Aspiration Scale is an 8-point scale during instrumental swallowing assessments such as the fiberoptic endoscopic swallow study, both indicating the localization of the airway leak and demonstrating the response to the assessment.
Oral Motor Dysfunction (OMD)
Time frame: Three Months
Oral motor dysfunction (OMD) assessment of the patients was performed by physical examination of the oropharyngeal mechanism. Lips, tongue, palate, cheeks, teeth, jaw, larynx, and oral reflexes were evaluated with 26 items in terms of lifting, pressing, extending, retraction, approximation, rolling, lateralization, movement, coordination, speed, tone, and strength. A scale of 1-4 was used for scoring (1=within functional limits, 2=mild impairment, 3=moderate impairment, 4=severe impairment). The total score ranged from 26 to 104, with higher scores indicating greater degree of impairment. Only a score of 26 was considered normal within functional limits.
Cranial Nerve Examination
Time frame: Three Months
Nervus trigeminus (V. cranial nerve), Nervus facialis (VII. cranial nerve), Nervus glossopharyngeus (IX. cranial nerve), Nervus vagus (X. cranial nerve) and Nervus hypoglossus (XII. cranial nerve) which are five cranial nerves involved in swallowing function were evaluated by the clinician.
Eating Assessment Tool-10 (EAT-10)
Time frame: Three Months
The Eating Assessment Tool-10 (EAT-10) was used to examine how the quality of life of the patients was affected because of their difficulty in swallowing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 33167752Vergara J, Lirani-Silva C, Brodsky MB, Miles A, Clave P, Nascimento W, Mourao LF. Potential Influence of Olfactory, Gustatory, and Pharyngolaryngeal Sensory Dysfunctions on Swallowing Physiology in COVID-19. Otolaryngol Head Neck Surg. 2021 Jun;164(6):1134-1135. doi: 10.1177/0194599820972680. Epub 2020 Nov 10.
- Background: PubMed 32460415Dziewas R, Warnecke T, Zurcher P, Schefold JC. Dysphagia in COVID-19 -multilevel damage to the swallowing network? Eur J Neurol. 2020 Sep;27(9):e46-e47. doi: 10.1111/ene.14367. Epub 2020 Jun 13. No abstract available.
- Background: PubMed 25358607Cheney DM, Siddiqui MT, Litts JK, Kuhn MA, Belafsky PC. The Ability of the 10-Item Eating Assessment Tool (EAT-10) to Predict Aspiration Risk in Persons With Dysphagia. Ann Otol Rhinol Laryngol. 2015 May;124(5):351-4. doi: 10.1177/0003489414558107. Epub 2014 Oct 30.
- 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. This study is not recruiting at the moment.
Gökhan C Törpü, BPT principal investigator
Bezmialem Vakif University
Müberra Tanrıverdi, PhD study director
Bezmialem Vakif University
Nahide Öztoprak, BPT study chair
Bezmialem Vakif University
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 COVID-19 and Dysphagia, run by Bezmialem Vakif 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Flexible Endoscopic Evaluation of Swallowing (FEES) (time frame: Three Months). The study lists 5 primary outcomes in all. 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 NCT06135207, 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 18 Nov 2023.