Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

31 ottobre 2021 aggiornato da: suhaib abdelzaker Mohamed, Assiut University

Sudden sensorineural hearing loss (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was 5-27/100,000 persons per year in the United states.2,3 The causative etiologies for SSNHL included viruses, microcirculation abnormalities, and autoimmune disorders. However, definitive evidence remains elusive.4,5 Currently, steroids are the treatment of choice due to their effects on the inner ear such as immunosuppression and circular enhancement.6,7 Combined systemic and intra-tympanic steroid treatment has previously been reported to be beneficial for SSNHL patients, with overall better treatment outcomes.8,9 However, due to the heterogeneous pathological nature and spontaneous recovery potential of the disease, few controlled studies exist in the literature. As a result, the treatment strategies of SSNHL remain a controversial issue in clinicalpractice .10 The condition exhibits a wide age distribution , with an average of 50-60 years and no sex preference. The hearing loss is unilateral in most Population studies of sudden sensorineural hearing loss cases, with bilateral involvement reported in less than 5%. 11 The severity of the hearing loss is divided roughly equally into mild, moderate, and severe profound. The configuration of the hearing loss varies and can affect high, low, or all frequencies. Tinnitus occurs in about 80% of patients, and vertigo, indicating an associated peripheral vestibular dysfunction, in about 30%. 12 The response to medical therapy shows inconsistent results regarding symptoms especially hearing loss may be due to the uncertainty about the cause of the disease and its progress. little is known about the factors which may contribute to either success or failure of the medical therapy.

Aim of work

  1. To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL
  2. To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

Patient and methods Study design The study will be conducted as across sectional observation study. Study setting ENT Department Assiut University Hospital outpatient clinic in the period between the 1st July 2019 end of June 2021.

Inclusion criteria All cases above 6 years presented with unilateral or bilateral ISSNHL Exclusion criteria Patient below 6 years old.

Data Collection

After fulfilling all inclusion and exclusion criteria all the patient will be subjected to:

  • Full History taking including : the residency, occupation, duration of the clinical symptoms , associated symptoms like tinnitus , vertigo and aural fullness, the presence of previous episodes of hearing loss, the presence of any chronic medical condition especially diabetes and hypertension and neurological history, the medication history and surgical history specially ear surgeries, in addition to family history if relevant.
  • Full medical examination including general examination with special emphasizing upon blood pressure measurements, full neurological examination, full ENT examination with vestibular testing especially in cases presented with vertigo
  • Laboratory investigation Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.

Renal function test Liver function test. Random blood sugar, oral glucose testing, HbA1c

audiological evaluation upon recruitment, all the patient will be subjected to audiological evaluation using audiogram where the hearing loss will be graded into mild, moderate, , sever and profound. speech discrimition will be graded into good ,fair and poor upon recruitment, all the patient will be subjected to audiological evaluation using ABR to asses retrocochlear pathology

Management plan

  1. If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
  2. Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.

An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.

Follow up All the patient will be subjected to audiological evaluation using the audiogram 2 weeks and one month after the initiation of the therapy to detect the treatment outcome.

Statistical analysis

  • Factors affecting the treatment outcome will be grouped into

    1. Age.
    2. Onset of the disease.
    3. . tinnitus.
    4. vertigo.
    5. audiogram to detect the degree of hearing loss mild,moderate severe profund .speech discrimition low frequencies versus high frequencies.
    6. Complete blood count test with differential to detect neutrophil lymphocyte monocyte ratio.
    7. Comorbidities as hypertension cardiac All those factors will be compared to each other and to the final hearing outcome using correlation coefficient, regression analysis using the SPSS 20 software.

      Ethical consideration:

      . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval.

      The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy.

      Privacy and confidentiality of all data will be assured .

  • The aim of the study will be explained to each patient before the beginning of theprocess.

Written consent will be obtained from those who are willing to participate in the study.

Privacy and confidentiality of all data will be assured .

  • Privacy and confidentiality of all data will be assured .
  • . The Study will be reviewed by the Assiut University medical ethical committee as a study applied on humans to get their final approval.

The aim of the study will be explained to each patient before the beginning of theprocess Written consent will be obtained from those who are willing to participate in thestudy.

Privacy and confidentiality of all data will be assured .

• The aim of the study will be explained to each patient before the beginning of theprocess.

Written consent will be obtained from those who are willing to participate in the study.

Privacy and confidentiality of all data will be assured .

• Privacy and confidentiality of all data will be assured .

Tipo di studio

Interventistico

Iscrizione (Effettivo)

40

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Assiut, Egitto
        • Assiut University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 90 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • All cases above 6 years presented with unilateral or bilateral ISSNHL

Exclusion Criteria:

  • Patient below 6 years old

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: the main group

Management plan

  1. If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.
  2. Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.

An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator

-If the patient come at first two weeks of onset of hearing loss the patient will be manged by oral corticosteroid in the form of ,prednisolone60mg in two divided doses for 2 weeks.

2-Patient will be manged by 5 sessions of intratympanic steroid after failure of systemic steroid and patient who come after 2 weeks of onset of hearing loss , each session will be 3 days apart. The injectable material will be 1ml of hydrocortisone 8ml. The injection will be done under local anesthesia and microscope magnification. A pack of lidocaine gel will be applied in the external canal for 10 minutes in EAC to induce anesthesia by using insulin syringe 1ml bore.

An 8 ml of hydrocortisone will be injected in the ME through posteroinferior part of TM All patients will receive antiviral therapy in the form of acyclovir,valcyclovir All the patient will receive vasodilator.

Altri nomi:
  • Microscopic Intratympanic steroid injection

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis ( in decibel )
Lasso di tempo: 18months
To detect if the duration between onset symptoms and start treatment ( in days) affect final hearing prognosis( in decibel) assessed by audiogram pre and post treatment
18months
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases and chronic kidney disease ) affect the final hearing prognosis in decibel
Lasso di tempo: 18months
to detect if presence of comorbidities ( diabetes, hypertension, coronary heart diseases) from history taking affect the final hearing prognosis measured by decibel assessed by audiogram pre and post treatment
18months
To detect if the severity of hearing loss symptoms in (decibel ) affect final hearing prognosis ( in decibel )
Lasso di tempo: 18 months
To detect if the degree of hearing loss symptoms in (decibel) affect final hearing assessed by audiogram pre and post treatmentprognosis ( in s assessed by audiogram pre and post treatment
18 months
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis
Lasso di tempo: 18 months
To detect if presence of associated presenting symptoms ( vertigo and tinnitus) affect the final hearing prognosis ( in decibel) assessed by audiogram pre and post treatment
18 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To detect if the age in years affect the final hearing prognosis
Lasso di tempo: 18 months
To detect if the age in years affect the final hearing prognosis assessed by audiogram pre and post treatment
18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis
Lasso di tempo: 18 months
to detect if unilateral or bilateral symptoms affect the final hearing prognosis assessed by pre and post treatment audiogram
18 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2019

Completamento primario (Effettivo)

1 giugno 2021

Completamento dello studio (Effettivo)

30 giugno 2021

Date di iscrizione allo studio

Primo inviato

24 settembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

31 ottobre 2021

Primo Inserito (Effettivo)

8 novembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 novembre 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 ottobre 2021

Ultimo verificato

1 ottobre 2021

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi