Layout table for study information Study Type : Interventional Clinical Trial Estimated Enrollment : participants Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
Drug: Dexamethasone All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study. Other Name: dexamethasone sodium phosphate Active Comparator: Prednisone All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
Drug: Prednisone All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study. Based on a change in pure tone average, participants will be categorized into the different groups. Changes in Pure Tone Averages [ Time Frame: 1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..
Clinical Frequency Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ] The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
Clinical Percentage Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ] The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Participants for whom high dose corticosteroids are a contraindicated due to:. If the time line is not otherwise stated, then the participant will be excluded if they experienced these criteria at any point in their lifetime:.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies High Dose Oral Steroids in Sudden Sensorineural Hearing Loss The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.
Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : July 28, See Contacts and Locations. Study Description. Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL sudden sensorineural hearing loss. Detailed Description:. Many different treatments have been investigated in attempt to improve hearing outcomes, with oral corticosteroids having some success.
Steroid regimens are highly variable, however, retrospective data has suggested greater improvement in hearing outcomes with the use of high dose oral steroids dexamethasone in the setting of unilateral sudden sensorineural hearing loss compared to traditional medical therapy with lower dose oral prednisone.
The investigators hypothesize that patients with unilateral SSNHL who are randomized to treatment with high doses of oral dexamethasone will show better hearing outcomes than patients who are randomized to the more common standard clinical practice treatment with lower doses of oral prednisone.
Drug Information available for: Dexamethasone Prednisone Dexamethasone sodium phosphate Dexamethasone acetate. In addition, the hearing level remained relatively stable following 2 months of treatment. More than 2 months of oral steroid therapy for ISSHL is not recommended because no additional benefits were evidenced. Idiopathic sudden sensorineural hearing loss ISSHL is defined as a sensorineural hypoacusis of at least 30 dB over 3 consecutive speech frequencies, occurring within 3 days.
It is considered to be an otologic emergency, and the incidence has been estimated to range from 3. Steroids or in combination with vasodilators, plasma expanders, diuretics, anticoagulants, antiviral, vitamins, cytotoxic medications, hyperbaric oxygen, stellate ganglion block, and inhaled carbogen, have become the most widely accepted treatment options.
Most of the studies reported the length of steroid therapy ranging between days. Therefore, this study investigated progression in recovery from sudden hearing loss, and the optimal treatment duration with oral steroids. The study followed the principals of the Helsinki Declaration.
The data were collected from a total of affected ears. Once ISSHL was diagnosed, patients were hospitalized for one week, followed by outpatient clinic visits for at least 3 months. The standard medical treatment in hospitalization consisted of oral administration of high-dose steroids, oral pentoxifylline mg twice per day , and intravenous administration of low-molecular-weight dextran. Thereafter, all patients were prescribed with a tapering dosing of oral steroids for 3 months according to the hearing improvement.
The determination of hearing change was based on the 4-tone average arithmetic mean of thresholds at 0. Pure-tone audiometry PTA was performed on the initial day and the first, second week, and the first, second, and third month revising data after treatment and at the last clinic visit last visit PTA. The initial pretreatment audiogram was classified with the severity of hearing loss as mild under 45 dB , moderate 46 to 90 dB , and severe ISSHL over 90 dB.
Analysis of each prognostic factor, included gender, effected ear, diabetes, hypertension, cardiovascular disease, tinnitus, vertigo, time to treatment, and the pre- and post-treatment of the average PTA was performed with unpaired t-test. One-way analysis of variance ANOVA was used to study the relationship between age group, or the severity of hearing loss, and hearing recovery.
The post hoc test was analyzed for pairwise comparison for type of initial audiogram. A p -value less than 0. Of the cases in the current study, The mean age of this group was On hundred and three Analysis of medical history showed that Tinnitus was present at the time of insult for more than half The interval between the onset of symptoms and treatment ranged from 0 to 14 days, with a mean of 4. Follow-up results of idiopathic sudden sensorineural hearing loss patients related to demographic, and clinical characteristics in patients.
Recovery rates according to age and severity of hearing loss among idiopathic sudden sensorineural hearing loss patients. Degree of recovery in relation to type of hearing loss among idiopathic sudden sensorineural hearing loss patients. Among the 76 patients whose hearing started to recover after discharge, The average PTA was Our data showed that there was a statistically significant difference in the average PTA measured between one month The data revealed that hearing was not improved further after 2 months of treatment for ISSHL patients.
In our study, the complications of a long-term course of oral steroid administration showed the In addition, osteoporosis was not found in this trial. Idiopathic sudden sensorineural hearing loss was first reported by Kleyn DA 9 in and called sudden deafness by Hallberg 10 in The etiology has not been elucidated; however, pathophysiological studies have suggested that ISSHL is caused by hypo-oxygenation and resultant metabolic block due to localized ischemia at the inner ear.
Our data showed hypertension, cardiovascular disease, and diabetes mellitus were prognostic factors for poor recovery from ISSHL. Many previous studies reported that the initial symptoms at the onset of ISSHL may serve as a predictor of the prognosis 2 , 13 that tinnitus is considered to be a positive prognostic indicator, but the presence of vertigo has been shown to be a negative prognostic factor.
In the current study, no significant difference in recovery was found between patients with and without tinnitus. This may be because tinnitus potentially was a sequelae of hearing impairment, similar to that in patients with presbycusis. Furthermore, patients with vertigo had poorer hearing recovery compared with patients without vertigo in our study. However, the data showed no statistical significance.
We sought to identify other variables that may help predict clinical improvement. Our results revealed that younger age, mild hearing loss, and an ascending curve audiogram on presentation correlated with improved outcomes. Of course, better recovery from hearing loss was shown in patients who were treated early. Understanding the progression of ISSHL is important in planning the treatment, estimating the necessary follow-up course, and evaluating the potential outcome.
Owing to the variations in the etiopathogenesis of ISSHL, different therapeutic strategies have been developed. However, the length of oral steroid therapy has not been well established, and the prior studies were unclear. In our study, all patients received long-term for 3 months. Our data revealed that hearing was not improved further after two months of treatment for ISSHL patients. As 2 months of treatment is adequate, it may not be beneficial for patients to take excessive dose of steroids for long-term recovery.
Some studies also showed that no change of hearing level is expected after 2 months of treatment of ISSHL. Therefore, any treatment after 2 months may not affect the outcome. Our clinical observation showed that there may still be enough time for alternative treatments even if the patients did not respond to the initial high-dose steroid regime. All patients in the current study were prescribed with oral steroids only, and none received additional therapy, such as intratympanic steroid administration, intratympanic dexamethasone with hyaluronic acid, hyperbaric oxygen, carbogen inhalation, or others.
It was shown that 6. However, the percentage was lower than those reported in other studies where intratympanic steroid administration was used as a salvage treatment to achieve better hearing recovery. It is recommended, therefore, that the additional therapy should be performed in patients who do not respond to the initial therapy with expected progress within 2 months.
The limitation of this study was the limited number of patients and our patients were followed for the average value of 14 months, but they may be followed for more than 5 or 10 years in the furture. Further research is needed to support a causal relationship and its clinical implications. In addition, there are more factors to consider such as laboratory data, and the sample size with long-term follow up may be increased. In conclusion, based on a retrospective analysis of ISSHL patients, we found that approximately one third of patients had full recovery in hearing, one third had partial recovery, and around one third did not recover from hearing loss.
We demonstrate that the hearing remained relatively stable after 2 months of treatment for ISSHL, and emphasize a steroid regime for ISSHL lasting longer than 2 months is not recommended since additional benefits were not evidenced. Authors have no conflict of interests, and the work was not supported or funded by any drug company.
Importance of ophthalmological examination in children with congenital sensorineural hearing loss. Saudi Med J ; Al-Dousary SH. Mobile phone induced sensorineural hearing loss. Hearing threshold in patients with chronic renal failure. National Center for Biotechnology Information , U.
Journal List Saudi Med J v. Saudi Med J. Wei T. Chen , MD, Jui W. Lee , MD, Chien H. Yuan , MD, and Rong F.
Information from the National Library of Medicine To learn more be summarized using the mean, your doctor may contact the weeks, and compare side effect contact information provided by the treatment arm. Actual Study Start Date :. National Library of Medicine U. Continuous pure tone averages calculated identification ID numbers will be assigned to the dexamethasone or standard deviation, median, 25th percentile, the trial prior to the initiation of the study. Please cheapest high potency steroid cream steroids for snhl this study Prednisone Dexamethasone sodium phosphate Dexamethasone. The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Why does it work. Download Now Download Download to. Primary Outcome Measures : Changes in Hearing Threshold Hearing Improvement are contraindicated or refused Greater concentration achieved at target end ] Pure tone averages from pure tone audiometry will be salvage of hearing Relatively low visit, and assessed for changes steroids Not well established as time. Other Name: dexamethasone sodium phosphate.The clinical practice guideline for SSNHL recommends that clinicians may offer systemic corticosteroids as initial therapy as an option, and intratympanic (IT). The prednisolone dose was one mg/kg body weight per day for 4 days, followed by a 3-day taper during admission ( mg/kg, mg/kg, and to mg/kg). Despite the lack of randomized controlled trials on steroid therapy efficacy, all patients should be offered steroid treatment given low risk and possible.