Audio Vestibular Functions in COVID 19 Patients in Sohag Governate

COVID19 Clinical Trial

Official title:

Audiovestibular Functions in Covid 19 Patients in Sohag Governate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04860193
• Other study ID #: Soh-Med-21-04-14
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• Source: Sohag University
• Contact: Yasmeen Mohamed
• Phone: 01019774326
• Email: emadrashad150150[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• previous history of hearing loss or otoneurological disease

Related Conditions & MeSH terms

• COVID19

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basic audiological evaluation:	Pure-tone audiometry.	3 months after infection
Primary	Basic audiological evaluation:	Acoustic immittance testing	3 months after infection
Primary	Basic audiological evaluation:	Speech audiometry	3 months after infection
Primary	Auditory evoked potentials:	Auditory brainstem response.	3 months after infection
Primary	Auditory evoked potentials	P300	3 months after infection
Primary	Effect on vestibular functions	Videonystagmography	3 months after infection
Primary	Effect on vestibular functions	Video Head Implus test VHIT.	3 months after infection
Primary	Effect on vestibular functions	Vestibular evoked myogenic potential.	3 months after infection
Primary	Effect on vestibular functions	Computerized Dynamic Posturography (CDP)	3 months after infection
Secondary	Effect on cognitive functions	Cognitive function assessment: By Montreal test	3 months after infection
Secondary	Vestibular questionnaire	Dizziness Handicap Inventory (DHI).	3 months after infection