The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders

Completed

• Conditions: Dysphagia; COVID-19

• Registration Number: NCT06135207
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study Start: 2022-06-27
• Primary Completion: 2022-10-23
• Study Completion: 2022-10-23
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-12
• Last Update Submitted: 2023-11-12
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Flexible Endoscopic Evaluation of Swallowing (FEES)	Three Months	Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).
Oral Motor Dysfunction (OMD)	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.
The Penetration - Aspiration Scale	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.
Cranial Nerve Examination	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)	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.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 İstanbul, Eyüp, Turkey