Audiological Assessment of Recovered Covid 19 Subjects.

NCT ID: NCT05052320

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Covid 19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Audiological assessment

TO assess audiological profile in recovered covid19 subjects

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa kamal Mostafa Mohamed

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mostafa Kamal Mostafa

Role: CONTACT

01111029396

Eman Abdelfatah sayed

Role: CONTACT

+201007238234

References

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Fancello V, Hatzopoulos S, Corazzi V, Bianchini C, Skarzynska MB, Pelucchi S, Skarzynski PH, Ciorba A. SARS-CoV-2 (COVID-19) and audio-vestibular disorders. Int J Immunopathol Pharmacol. 2021 Jan-Dec;35:20587384211027373. doi: 10.1177/20587384211027373.

Reference Type BACKGROUND
PMID: 34142589 (View on PubMed)

Almufarrij I, Munro KJ. One year on: an updated systematic review of SARS-CoV-2, COVID-19 and audio-vestibular symptoms. Int J Audiol. 2021 Dec;60(12):935-945. doi: 10.1080/14992027.2021.1896793. Epub 2021 Mar 22.

Reference Type RESULT
PMID: 33750252 (View on PubMed)

Dharmarajan S, Bharathi MB, Sivapuram K, Prakash BG, Madhan S, Madhu A, Devi GN, Aliya SA, Ramya SB. Hearing Loss-a Camouflaged Manifestation of COVID 19 Infection. Indian J Otolaryngol Head Neck Surg. 2021 Dec;73(4):494-498. doi: 10.1007/s12070-021-02581-1. Epub 2021 May 10.

Reference Type RESULT
PMID: 33996529 (View on PubMed)

Dusan M, Milan S, Nikola D. COVID-19 caused hearing loss. Eur Arch Otorhinolaryngol. 2022 May;279(5):2363-2372. doi: 10.1007/s00405-021-06951-x. Epub 2021 Jul 8.

Reference Type RESULT
PMID: 34235578 (View on PubMed)

Other Identifiers

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AARC19

Identifier Type: -

Identifier Source: org_study_id

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