CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
systemic and intratympanic injection of steoiddrug
Likely dose
systemic and intratympanic injection of steoid 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05112354
NCT05112354Phase 2Completed

Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss

Assiut University·interventional·Posted Nov 8, 2021·Updated Nov 8, 2021

In Brief

A Phase 2 clinical trial evaluating systemic and intratympanic injection of steoid for Idiopathic Sudden SNHL. Completed, enrolled 40 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 8, 2021
Enrollment StartDec 1, 2019
Primary CompletionJun 1, 2021
Study CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.6 years ago

Interventions

systemic and intratympanic injection of steoiddrug

-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.