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Oral steroid regimens for idiopathic sudden sensorineural hearing loss
Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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:.
We're building a better ClinicalTrials. Check it out and tell us what you think! 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 : August 27, See Contacts and Locations. View this study on Beta. 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.
FDA Resources. Arms and Interventions. 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. Outcome Measures. Primary Outcome Measures : Changes in Hearing Threshold Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ] Pure tone averages from pure tone audiometry will be recorded for participants at each visit, and assessed for changes in pure tone average over time.
Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.
The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Drug: Dexamethasone Drug: Prednisone. Phase 2. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. 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.
Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Active Comparator: Dexamethasone All subject identification 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.
Other Name: Deltasone. August 21, Key Record Dates.
❾-50%}Prednisone for hearing loss.Sudden Hearing Loss
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Drug: Dexamethasone Drug: Prednisone. Phase 2. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. 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.
Actual Study Start Date :. Estimated Primary Completion Date :. More ». June 6, Injecting steroids into the middle ear works just as well as taking them orally when it comes to restoring hearing for sudden deafness patients.
This finding, the result of a large clinical trial comparing the therapies, will help doctors choose the best treatment for patients with this condition. Sudden deafness, also called sudden sensorineural hearing loss, is an emergency medical condition that affects several thousand people annually, usually between the ages of 40 and It often arises without an obvious cause and occurs in one ear all at once or over a period of up to 3 days.
Oral steroids, such as prednisone, are usually prescribed over the course of 2 weeks to restore hearing. Taking intratympanic corticosteroids as well as systemic corticosteroids might result in a small improvement in hearing compared to systemic corticosteroids alone, but it is uncertain how many people would notice an improvement.
As above, intratympanic treatment may cause some side effects, but we cannot be certain of the number of people who may experience these.
For people having additional treatment for sudden deafness when their first treatment did not work. When compared to no treatment or a placebo dummy treatment, intratympanic corticosteroids may result in a much larger number of people having an improvement in their hearing but may only improve hearing slightly.
As with first treatment, intratympanic injections might cause some side effects, such as pain or dizziness at the time of the injection, or development of a small hole in the ear drum. We are not certain how often these side effects will happen. We are very uncertain whether adding intratympanic treatment to systemic treatment will result in an improvement in hearing. We considered most of the evidence we found to be of low or very low certainty. This was because there were often some problems with how the studies had been carried out, there may have been few people included in the studies and sometimes results from different studies were conflicting.
Therefore, the conclusions of this review may change as new studies are published. Most of the evidence in this review is low- or very low-certainty, therefore it is likely that further studies may change our conclusions. For primary therapy, intratympanic corticosteroids may have little or no effect compared with systemic corticosteroids. There may be a slight benefit from combined treatment when compared with systemic treatment alone, but the evidence is uncertain.
For secondary therapy, there is low-certainty evidence that intratympanic corticosteroids, when compared to no treatment or placebo, may result in a much higher proportion of participants whose hearing is improved, but may only have a small effect on the change in hearing threshold.
It is very uncertain whether there is additional benefit from combined treatment over systemic steroids alone. Idiopathic sudden sensorineural hearing loss ISSNHL is common, and defined as a sudden decrease in sensorineural hearing sensitivity of unknown aetiology. Systemic corticosteroids are widely used, however their value remains unclear. Intratympanic corticosteroids were given as primary or secondary treatment after failure of systemic therapy.
Our primary outcome was change in hearing threshold with pure tone audiometry. Secondary outcomes included the proportion of people whose hearing improved, final hearing threshold, speech audiometry, frequency-specific hearing changes and adverse effects.
Simmons, Natural history of sudden sensorineural hearing loss. Ann Otol Rhinol Laryngol, Parnes, Treatment of sudden sensorineural hearing loss: II. A Meta-analysis. Rauch, S. Idiopathic sudden sensorineural hearing loss. N Engl J Med, Schuknecht, H. Donovan, The pathology of idiopathic sudden sensorineural hearing loss. Arch Otorhinolaryngol, Linthicum, F. Doherty, and K. Berliner, Idiopathic sudden sensorineural hearing loss: vascular or viral?
Nakashima, T. Yanagita, Outcome of sudden deafness with and without vertigo. Saunders, J. Aarnisalo, A. Suoranta, and J. Ylikoski, Magnetic resonance imaging findings in the auditory pathway of patients with sudden deafness. Suzuki, M. Fortnum, H. Health Technol Assess, Koors, P. Thacker, and D. Coelho, ABR in the diagnosis of vestibular schwannomas: a meta-analysis. Am J Otolaryngol, Awad, Z. Huins, and D. Pothier, Antivirals for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev, Wang, C.
Agarwal, L. Pothier, Vasodilators and vasoactive substances for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev, 4 : p. Wilson, W. Byl, and N. Laird, The efficacy of steroids in the treatment of idiopathic sudden hearing loss.
More ». June 6, Injecting steroids into the middle ear works just as well as taking them orally when it comes to restoring hearing for sudden deafness patients.
This finding, the result of a large clinical trial comparing the therapies, will help doctors choose the best treatment for patients with this condition. Sudden deafness, also called sudden sensorineural hearing loss, is an emergency medical condition that affects several thousand people annually, usually between the ages of 40 and It often arises without an obvious cause and occurs in one ear all at once or over a period of up to 3 days.
Oral steroids, such as prednisone, are usually prescribed over the course of 2 weeks to restore hearing. There is only a 2- to 4-week window of time for treatment before hearing loss becomes permanent. Recently, doctors have started injecting steroids directly into the middle ear — a procedure called intratympanic treatment. This technique is thought to deliver more of the drug to the ear and to avoid some of the side effects that can come along with oral steroids. The side effects of oral therapy can be mild, like weight gain, mood changes and sleep disruption, or more serious, like high blood pressure and elevated blood sugar.
Side effects of injected steroids are usually local, such as ear infection and vertigo. However, up until now, no study had compared the 2 treatments to see whether direct injection worked as well as oral steroids.
To investigate, Dr. Steven Rauch of Harvard Medical School and the Massachusetts Eye and Ear Infirmary led a team of investigators from 16 medical centers nationwide in a clinical trial involving more than patients.
The results were published in the May 25,issue of the Journal of the American Medical Association. The study tested the treatments as they are usually given in the clinic.
For oral steroid therapy, patients received 60 milligrams of prednisone for 14 days, followed by a tapering-off period of 5 days. The other group was given 40 milligrams of methylprednisolone injected directly through the eardrum 4 times over the course of 2 weeks.
The study followed the recovery of these patients for 6 months, measuring the success of the treatments based on hearing tests at the first and second weeks, and months 2 and 6. Under both regimens, patients recovered their hearing to about the same extent at 2 and 6 months. The oral steroid patients experienced typical symptoms, such as sleep, mood and appetite changes. The injected steroid patients had pain at the injection site and vertigo; a few had ear infections and a perforated eardrum.
Most symptoms cleared up by 6 months. Nevertheless, the difference showed that while the treatments were equally effective, they might not be equally appropriate for every patient. People with sudden deafness should discuss the risks and benefits of both treatments with their doctor.
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localhost › Connect to Care › Hearing loss. Injecting steroids into the middle ear works just as well as taking them orally when it comes to restoring hearing for sudden deafness. Injecting steroids into the middle ear works just as well as taking them orally when it comes to restoring hearing for sudden deafness. Although controversial, the most commonly prescribed treatment for SSNHL is the use of oral steroids. A randomized, placebo-controlled trial in Steroid regimens are highly variable, however, retrospective data has suggested greater improvement in hearing outcomes with the use of high. 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.Jump to navigation. Sudden hearing loss is a condition characterised by the sudden onset usually within 72 hours of reduced or absent hearing. People have often used corticosteroids — a type of anti-inflammatory medicine - to treat the condition.
These medicines are usually taken by mouth or injected into the body known as systemic corticosteroids , but can also be given as an injection directly into the middle ear, through the eardrum known as intratympanic corticosteroids. It is not clear whether intratympanic treatment with corticosteroids is effective, or which of these treatments intratympanic or systemic is best for treating this condition.
We searched for all relevant studies in the medical literature, compared the results and summarised the evidence. We also assessed how certain the evidence was, considering factors such as study size and the way studies were conducted.
Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty. We found 30 studies that included people. These studies compared intratympanic treatment with corticosteroids with no treatment, with placebo sham or dummy treatment and with corticosteroids that were taken by mouth or injection into the body systemic corticosteroids. We took into account whether people were having their first treatment for sudden deafness or whether they had previously had some other kind of treatment which had not worked.
We did not find any studies that compared intratympanic corticosteroids to no treatment or placebo dummy treatment. Intratympanic corticosteroids might result in little or no difference in hearing when compared to people who receive systemic corticosteroids, and might make little to no difference in the number of people whose hearing improves. The side effects may be different with these two types of treatment. With intratympanic treatment, people may have an increase in the risk of dizziness or ear pain as compared to systemic corticosteroids, typically at the time of injection, and some may develop a small hole in the ear drum.
However, systemic treatment may also cause an increased risk of different side effects, such as problems with sugar levels in the blood. Taking intratympanic corticosteroids as well as systemic corticosteroids might result in a small improvement in hearing compared to systemic corticosteroids alone, but it is uncertain how many people would notice an improvement. As above, intratympanic treatment may cause some side effects, but we cannot be certain of the number of people who may experience these.
For people having additional treatment for sudden deafness when their first treatment did not work. When compared to no treatment or a placebo dummy treatment, intratympanic corticosteroids may result in a much larger number of people having an improvement in their hearing but may only improve hearing slightly.
As with first treatment, intratympanic injections might cause some side effects, such as pain or dizziness at the time of the injection, or development of a small hole in the ear drum. We are not certain how often these side effects will happen. We are very uncertain whether adding intratympanic treatment to systemic treatment will result in an improvement in hearing. We considered most of the evidence we found to be of low or very low certainty.
This was because there were often some problems with how the studies had been carried out, there may have been few people included in the studies and sometimes results from different studies were conflicting. Therefore, the conclusions of this review may change as new studies are published. Most of the evidence in this review is low- or very low-certainty, therefore it is likely that further studies may change our conclusions. For primary therapy, intratympanic corticosteroids may have little or no effect compared with systemic corticosteroids.
There may be a slight benefit from combined treatment when compared with systemic treatment alone, but the evidence is uncertain. For secondary therapy, there is low-certainty evidence that intratympanic corticosteroids, when compared to no treatment or placebo, may result in a much higher proportion of participants whose hearing is improved, but may only have a small effect on the change in hearing threshold.
It is very uncertain whether there is additional benefit from combined treatment over systemic steroids alone. Idiopathic sudden sensorineural hearing loss ISSNHL is common, and defined as a sudden decrease in sensorineural hearing sensitivity of unknown aetiology.
Systemic corticosteroids are widely used, however their value remains unclear. Intratympanic corticosteroids were given as primary or secondary treatment after failure of systemic therapy. Our primary outcome was change in hearing threshold with pure tone audiometry.
Secondary outcomes included the proportion of people whose hearing improved, final hearing threshold, speech audiometry, frequency-specific hearing changes and adverse effects. We included 30 studies, comprising analysed participants. Some studies had more than two treatment arms and were therefore relevant to several comparisons. Studies investigated intratympanic corticosteroids as either primary initial therapy or secondary rescue therapy after failure of initial treatment.
Intratympanic corticosteroids versus systemic corticosteroids as primary therapy. We identified 16 studies participants. Intratympanic therapy may result in little to no improvement in the change in hearing threshold mean difference MD We found little to no difference in the proportion of participants whose hearing was improved risk ratio RR 1. Intratympanic therapy may result in little to no difference in the final hearing threshold MD Intratympanic therapy may increase the number of people who experience vertigo or dizziness RR 2.
Intratympanic plus systemic corticosteroids combined therapy versus systemic corticosteroids alone as primary therapy. We identified 10 studies participants. Combined therapy may have a small effect on the change in hearing threshold MD The evidence is very uncertain as to whether combined therapy changes the proportion of participants whose hearing is improved RR 1.
Combined therapy may result in slightly lower more favourable final hearing thresholds but the evidence is very uncertain, and it is not clear whether the change would be important to patients MD Some adverse effects only occurred in those who received combined therapy. Intratympanic corticosteroids versus no treatment or placebo as secondary therapy.
We identified seven studies participants. Intratympanic therapy may have a small effect on the change in hearing threshold MD Intratympanic therapy may result in a much higher proportion of participants whose hearing is improved RR 5.
Intratympanic therapy may result in lower more favourable final hearing thresholds MD Some adverse effects only occurred in those who received intratympanic injection. Intratympanic plus systemic corticosteroids combined therapy versus systemic corticosteroids alone as secondary therapy. We identified one study with 76 participants. Change in hearing threshold was not reported. Combined therapy may result in a higher proportion with hearing improvement, but the evidence is very uncertain RR 2.
Adverse effects were poorly reported with only data for persistent tympanic membrane perforation rate 8. Treatment of sudden hearing loss with corticosteroids applied into the middle ear What is sudden hearing loss? How is it treated? What did we want to find out? What did we do? What did we find? For people having their first treatment for sudden deafness We did not find any studies that compared intratympanic corticosteroids to no treatment or placebo dummy treatment.
For people having additional treatment for sudden deafness when their first treatment did not work When compared to no treatment or a placebo dummy treatment, intratympanic corticosteroids may result in a much larger number of people having an improvement in their hearing but may only improve hearing slightly. What are the limitations of the evidence? How up-to-date is this evidence? The evidence in this Cochrane Review is current to 23 September Authors' conclusions:.
Search strategy:. Selection criteria:. Data collection and analysis:. Main results:. Intratympanic corticosteroids versus systemic corticosteroids as primary therapy We identified 16 studies participants. Intratympanic plus systemic corticosteroids combined therapy versus systemic corticosteroids alone as primary therapy We identified 10 studies participants. Intratympanic corticosteroids versus no treatment or placebo as secondary therapy We identified seven studies participants.
Intratympanic plus systemic corticosteroids combined therapy versus systemic corticosteroids alone as secondary therapy We identified one study with 76 participants. Health topics:. Our evidence Featured reviews Podcasts What are systematic reviews?
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