Audiological Assessment of Recovered Covid 19 Subjects.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05052320
Collaborator
(none)
70
18

Study Details

Study Description

Brief Summary

To assess the audiological profile in recovered covid 19 subjects in comparison with control group.

Condition or Disease Intervention/Treatment Phase
  • Device: Audiological assessment

Detailed Description

The outbreak of novel Severe Acute Respiratory Syndrome Corona virus type 2 (nSARS-CoV-2) infection in Wuhan, China in December 2019 has had impact on the world, resulting in over 2.2 million deaths globally The world envisioned sufferings of high proportions of losses in terms of health,finances and importantly, life.

The common symptoms including fever, cough, fatigue and gastrointestinal disorders have been well documented. Sensorineural hearing loss has been more commonly implicated in these patients although a few have exhibited conductive hearing loss. theViral upper respiratory tract infections have linked to new cases of otitis media. Although There is some controversy regarding the significance of viral species, but the human corona virus has been isolated from middle ear fluid and linked to otitis media in children. Most patients affected are asymptomatic or experience mild symptoms.

Various theories explaining the involvement of the ear following covid infection have been pos tulated, which include immune mediated damage,haematogenous spread, ischaemia theory, inflammation of auditory pathway components, presence of angiotensin converting enzyme receptors (ACE2) receptors in neurons and glial cell.

The hearing loss in COVID-19 could also be the consequence of therapy with chloroquine and hydroxychloroquine, which are part of clinical practice guidelines for COVID-19 treatment in several countries . These drugs are used for the treatment of malaria and some chronic inflammatory diseases as well. It is well known that these medications can induce hearing loss. Ototoxicity of chloroquine and hydroxy- chloroquine is the result of inner ear damage . The recommended dose of these drugs for COVID-19 treatment is higher than for malaria; therefore, ototoxic effect could be higher.Though many vaccines were intro- duced, the disease has hit second and third waves in many countries, elevating the number of infected individuals getting infected .

Some studies reported that the COVID-19 group had significantly poorerhearing thresholds at high frequencies. In addition, the amplitudes of transient evoked otoacoustic emissions ,in two of thesestudies were significantly lower for the COVID-19 group.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Audiological Assessment of Recovered Covid 19 Subjects.
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Audiological assessment of recovered covid 19 subjects [base line]

    To evaluate the audiological profile of recoveredcovid 19 subjects in comparison with control group

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Age 18_50
Exclusion Criteria:
  1. History of previous ear symptoms, tympanic membrane perforations,ear trauma or ear surgeries

  2. Evidence of systemic illness as Diabetes mellitus, Renal disease, patients received ototoxic drugs.

  3. Evidence of neurologicl or psychiatric disease.

  4. covid 19 Patients not maintaining saturation and requiring O2 support and intensive care unit patient.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mostafa kamal Mostafa Mohamed, Resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05052320
Other Study ID Numbers:
  • AARC19
First Posted:
Sep 22, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021