Clinical trial NCT06135207: The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
Official title: The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Dysphagia
Keywords: COVID-19
Dysphagia
Flexible endoscopic swallowing study
Oral motor dysfunction
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18, who applied to the dysphagia outpatient clinic.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Suffering from dysphagia
* Not having mental retardation

Exclusion Criteria:

* Patients who did not have swallowing difficulties
* Refused to participate in the study

Primary outcomes:
measure: Flexible Endoscopic Evaluation of Swallowing (FEES)
timeFrame: Three Months
measure: The Penetration - Aspiration Scale
timeFrame: Three Months
measure: Oral Motor Dysfunction (OMD)
timeFrame: Three Months
measure: Cranial Nerve Examination
timeFrame: Three Months
measure: Eating Assessment Tool-10 (EAT-10)
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University
state: Eyüp
Study officials:
affiliation: Bezmialem Vakif University
name: Gökhan C Törpü, BPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Bezmialem Vakif University
name: Müberra Tanrıverdi, PhD
role: STUDY_DIRECTOR
affiliation: Bezmialem Vakif University
name: Nahide Öztoprak, BPT
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Ömer F Çalım, PhD
role: STUDY_CHAIR
affiliation: Bezmialem Vakif University
name: Orhan Özturan, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Dziewas 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.
citation: Cheney 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.