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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06135207
• Other study ID #: BezmialemVU-GCT-02
• Status: Completed
• Start date: June 27, 2022
• Est. completion date: October 23, 2022

Study information

• Verified date: November 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 23, 2022
• Est. primary completion date: October 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Deglutition Disorders
• Dysphagia

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Eyüp

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flexible Endoscopic Evaluation of Swallowing (FEES)	Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).	Three Months
Primary	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.	Three Months
Primary	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.	Three Months
Primary	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.	Three Months
Primary	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.	Three Months