Audio Vestibular Functions in COVID 19 Patients in Sohag Governate

NCT04860193 | Completed

• 1 other identifier: Soh-Med-21-04-14
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

There is evidence that up to 30% of COVID-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in COVID-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by COVID-19.This study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed COVID19 patients.

Conditions

COVID19

Outcome Measures

Primary Outcomes (9)

• Basic audiological evaluation:

  Pure-tone audiometry.

  3 months after infection

• Basic audiological evaluation:

  Acoustic immittance testing

  3 months after infection

• Basic audiological evaluation:

  Speech audiometry

  3 months after infection

• Auditory evoked potentials:

  Auditory brainstem response.

  3 months after infection

• Auditory evoked potentials

  P300

  3 months after infection

• Effect on vestibular functions

  Videonystagmography

  3 months after infection

• Effect on vestibular functions

  Video Head Implus test VHIT.

  3 months after infection

• Effect on vestibular functions

  Vestibular evoked myogenic potential.

  3 months after infection

• Effect on vestibular functions

  Computerized Dynamic Posturography (CDP)

  3 months after infection

Secondary Outcomes (2)

• Effect on cognitive functions

  3 months after infection

• Vestibular questionnaire

  3 months after infection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The present study will include 100 of randomly selected patients who were had been confirmed to be infection with COVID 19 virus, age ranged from 20-50 years. The investigation will be done three months after infection and after being sure that the patient become noninfectious.

You may qualify if:

• \- Well educated patients Age: range between 20 to 50 years No previous history of hearing loss or otoneurologic disease
• Well confirmed COVID 19 patients:
• patients who were diagnosed with coronavirus from
• symptoms: fever, cough, generalized malaise, dyspnea.
• Laboratory finding: abnormalities have been observed in Complete blood count (CBC), high C-reactive protein and ferritin, elevated D-dimer.
• Imaging: Chest CT scan: bilateral ground glass opacities, crazy paving, and consolidation.
• nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction testing (RT-PCR).

You may not qualify if:

• previous history of hearing loss or otoneurological disease

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Yasmeen Mohamed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 26, 2021
• Study Start: August 14, 2021
• Primary Completion: December 10, 2021
• Study Completion: March 18, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

EG (1)