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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT06135207
Collaborator
(none)
75
1
3.9
19.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders
    Actual Study Start Date :
    Jun 27, 2022
    Actual Primary Completion Date :
    Oct 23, 2022
    Actual Study Completion Date :
    Oct 23, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Flexible Endoscopic Evaluation of Swallowing (FEES) [Three Months]

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

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bezmialem Vakıf University İstanbul Eyüp Turkey 34230

    Sponsors and Collaborators

    • Bezmialem Vakif University

    Investigators

    • Principal Investigator: Gökhan C Törpü, BPT, Bezmialem Vakif University
    • Study Director: Müberra Tanrıverdi, PhD, Bezmialem Vakif University
    • Study Chair: Nahide Öztoprak, BPT, Bezmialem Vakif University
    • Study Chair: Ömer F Çalım, PhD, Bezmialem Vakif University
    • Study Chair: Orhan Özturan, PhD, Bezmialem Vakif University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gökhan Can TÖRPÜ, Principal Investigator, Bezmialem Vakif University
    ClinicalTrials.gov Identifier:
    NCT06135207
    Other Study ID Numbers:
    • BezmialemVU-GCT-02
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gökhan Can TÖRPÜ, Principal Investigator, Bezmialem Vakif University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2023