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

NCT06135207 | Completed

• 1 other identifier: BezmialemVU-GCT-02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Dysphagia

Keywords

COVID-19; Dysphagia; Flexible endoscopic swallowing study; Oral motor dysfunction

Outcome Measures

Primary Outcomes (5)

• Flexible Endoscopic Evaluation of Swallowing (FEES)

  Swallowing disorders of the patients were evaluated with fiberoptic endoscopic swallowing study (FEES).

  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.

  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.

  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.

  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.

  Three Months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18, who applied to the dysphagia outpatient clinic.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Eyüp, 34230, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33167752 BACKGROUND

• 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.

  PMID: 32460415 BACKGROUND

• 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.

  PMID: 25358607 BACKGROUND

MeSH Terms

Conditions

COVID-19; Deglutition Disorders

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gökhan C Törpü, BPT

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

• Müberra Tanrıverdi, PhD

  Bezmialem Vakif University

  STUDY DIRECTOR

• Nahide Öztoprak, BPT

  Bezmialem Vakif University

  STUDY CHAIR

• Ömer F Çalım, PhD

  Bezmialem Vakif University

  STUDY CHAIR

• Orhan Özturan, PhD

  Bezmialem Vakif University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: June 27, 2022
• Primary Completion: October 23, 2022
• Study Completion: October 23, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)