Dataset Information

Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial.

ABSTRACT:

Background

Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28-57% cases. Glucocorticoids, administered through oral or intratympanic way, are currently regularly and standardly applied for ISSNHL to improve the hearing outcome. However, the vestibular prognosis of ISSNHL after routine treatments remains seldom explored. This study aims to compare the effectiveness of oral and intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.

Methods/design

A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. Seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo or imbalance will be recruited and randomized into either oral or intratympanic glucocorticoid therapy group with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, cervical vestibular evoked myogenic potential, and ocular vestibular evoked myogenic potential; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessments of primary outcomes will be performed at baseline and at 4 and 8?weeks post-randomization, while assessments of secondary outcomes will be performed at baseline and 1, 2, 4, and 8?weeks post-randomization.

Discussion

Previous intervention studies of ISSNHL included only hearing outcomes, with little attention paid on the prognosis of vestibular dysfunction. This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. The efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone.

Trial registration

ClinicalTrials.gov NCT03974867 . Registered on 23 July 2019.

SUBMITTER: Hao W

PROVIDER: S-EPMC7477872 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial.

Hao Weiming W Zhao Liping L Yu Huiqian H Li Huawei H

Trials 20200722 1

<h4>Background</h4>Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28-57% cases. Glucocorticoids, administered through oral or intratympanic way, are currently regularly and standardly applied for ISSNHL to improve the hearing outcome. ...[more]

PMID: 32698830

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Project description:IntroductionTo compare inpatient treated patients with idiopathic (ISSNHL) and non-idiopathic sudden sensorineural hearing loss (NISSNHL) regarding frequency, hearing loss, treatment and outcome.MethodsAll 574 inpatient patients (51% male, median age: 60 years) with ISSNHL and NISSNHL, who were treated in federal state Thuringia in 2011 and 2012, were included retrospectively. Univariate and multivariate statistical analyses were performed.ResultsISSNHL was diagnosed in 490 patients (85%), NISSNHL in 84 patients (15%). 49% of these cases had hearing loss due to acute otitis media, 37% through varicella-zoster infection or Lyme disease, 10% through Menière disease and 7% due to other reasons. Patients with ISSNHL and NISSNHL showed no difference between age, gender, side of hearing loss, presence of tinnitus or vertigo and their comorbidities. 45% of patients with ISSNHL and 62% with NISSNHL had an outpatient treatment prior to inpatient treatment (p < 0.001). The mean interval between onset of hearing loss to inpatient treatment was shorter in ISSNHL (7.7 days) than in NISSNHL (8.9 days; p = 0.02). The initial hearing loss of the three most affected frequencies in pure-tone average (3PTAmax) scaled 72.9 dBHL ± 31.3 dBHL in ISSNHL and 67.4 dBHL ± 30.5 dBHL in NISSNHL. In the case of acute otitis media, 3PTAmax (59.7 dBHL ± 24.6 dBHL) was lower than in the case of varicella-zoster infection or Lyme disease (80.11 dBHL ± 34.19 dBHL; p = 0.015). Mean absolute hearing gain (Δ3PTAmaxabs) was 8.1 dB ± 18.8 dB in patients with ISSNHL, and not different in NISSNHL patients with 10.2 dB ± 17.6 dB. A Δ3PTAmaxabs ≥ 10 dB was reached in 34.3% of the patients with ISSNHL and to a significantly higher rate of 48.8% in NISSNHL patients (p = 0.011).ConclusionsISSNHL and NISSNHL show no relevant baseline differences. ISSNHL tends to have a higher initial hearing loss. NISSHNL shows a better outcome than ISSNHL.

Project description:BackgroundThe standard treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) constitutes of systemic oral corticosteroid. Although oral corticosteroid might revert the acute deafness, some patients with ISSNHL display a more treatment refractory course. For these patients, corticosteroid installed directly into the middle ear has become a more frequent treatment, due to the potential benefits of a high, local concentration compared to a systemic administration. As such, for patients being refractory to standard treatment, intratympanic injection of a high dosage of corticosteroid as salvage therapy may be beneficial.ObjectivesTo evaluate the efficacy of intratympanic corticosteroid (ITC) as a salvage treatment of ISSNHL.MethodsA systematic literature search was performed in relevant databases. Both randomized trials and observational studies were considered for inclusion. The risk of bias was evaluated using the Cochrane risk of bias tool (randomized trials) or ROBINS-I tool (observational studies). Meta-analysis was performed to investigate the improvement of PTA (dB) and number of patients displaying recovery following salvage ITC injections. Occurrence of serious side effects was investigated. Finally, the certainty of the evidence was evaluated using the GRADE approach.ResultsEleven relevant studies were identified (4 randomized trials and 7 observational studies). Both observational and randomized trials showed that salvage ITC significantly increased the number of patients displaying recovery. No serious adverse events were identified in any of the included studies. The certainty of evidence ranged from moderate to very low, due to risk of bias, imprecision, and heterogeneity.ConclusionCollectively, our findings indicate that salvage ITC treatment may be a beneficial and safe treatment for patients with sudden hearing loss, who otherwise are refractory to standard treatment approaches. However, the evidence level indicates need for a cautious interpretation of especially the magnitude of effect and thus the extrapolation on how much the individual may improve from this treatment. Furthermore, it remains to be investigated whether treatment outcomes may vary across different patient groups presenting with ISSNHL. This potential variation in treatment response should be kept in mind, when counselling the patient.Trial registration numberThe protocol is registered in PROSPERO. Registration number: CRD42019130586.

Project description:ImportanceTo our knowledge, evidence-based recommendations on the intratympanic vs systemic administration of corticosteroids for the treatment of idiopathic sudden sensorineural hearing loss remain unestablished, and contradictory conclusions have been reported in previous meta-analyses.ObjectiveTo compare recovery from idiopathic sudden sensorineural hearing loss based on systemic, intratympanic, or a combined treatment with corticosteroids as first-line treatment.Data sourcesWe adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We searched PubMed, Embase, OvidSP, CINAHL, and Cochrane Library from January 1, 1966, to July 1, 2018. This study was registered in the International Prospective Register of Systematic Reviews (CRD42018109314).Study selectionWe included randomized studies. Included studies must have excluded identifiable causes. Corticosteroids must have been administered solitarily. We excluded studies that did not define hearing loss as a minimum 30 dB within 72 hours.Data extraction and synthesisWe identified 170 titles, of which 56 (32.9%) were eligible for full-text screening. We independently extracted data. We applied a fixed-effects model to investigate our objectives.Main outcomes and measureWe aimed to (1) estimate the difference in mean pure tone average (PTA) gain in decibels from intratympanic treatment vs systemic treatment and (2) investigate odds ratios for recovery between the different treatment groups.ResultsWe included 7 eligible studies. A total of 710 patients were allocated to receive either intratympanic treatment (IT group, 235 [33%]), systemic treatment (ST group; 325 [46%]) or combined intratympanic and systemic treatment (CB group; 150 [21%]). The PTA was measured by taking the mean of 4 frequencies: 4 studies measured at 500, 1000, 2000, and 3000 Hz and 3 studies measured at 500, 1000, 2000, and 4000 Hz. The ST group had a 2.01-dB higher PTA gain (95% CI, -5.61 dB to 1.59 dB; P?=?.96; I2?=?0%) compared with the IT group and the odds for achieving complete recovery was not significantly different at an odds ratio of 0.94 (95% CI, 0.61 to 1.44; P?=?.19; I2?=?34.5%). For the CB group vs the ST group, the odds ratio was 1.11 (95% CI, 0.68 to 1.82; P?=?.75; I2?=?0%). The analysis of the CB group vs IT group comprised only 2 studies.Conclusions and relevanceThis study does not suggest that corticosteroid delivered intratympanically is more beneficial than systemic treatment in the case of moderate to severe idiopathic sudden sensorineural hearing loss. There were no indications that combined treatment was associated with improved hearing outcomes compared with either systemic or intratympanic treatment.

Project description:ImportancePatients with idiopathic sudden sensorineural hearing loss (ISSNHL) often experience permanent hearing impairment, which could result in psychological perturbations. However, the relationship between ISSNHL and affective disorders, including depression, anxiety, and bipolar disorder, has not been fully evaluated.ObjectiveTo investigate the potential relationship between ISSNHL and affective disorders using nationwide representative cohort sample data.Design, setting, and participantsThis study used a nationwide propensity score-matched cohort sample from the Korean National Health Insurance Service database from 2002 through 2013, which comprises data from approximately 1 million patients. The study included 1425 patients with ISSNHL and 7125 individuals without ISSNHL who were matched using propensity score matching, according to sociodemographic factors and enrollment year.Main outcomes and measuresSurvival analysis, the log-rank test, and Cox proportional hazards regression models were used to calculate the incidence, survival rate, and hazard ratio (HR) of developing affective disorders (anxiety, depression, and bipolar disorder) for each group.ResultsOf the total study population of 8550 (51.5% female), 961 developed affective disorders during the 11-year follow-up: 225 in the ISSNHL group (15.8%) and 736 in the comparison group (10.3%). We examined a total of 96 885.5 person-years (81 177.4 person-years in the comparison group and 15 708.1 person-years in the ISSNHL group). The incidence of affective disorders was 14.3 per 1000 person-years in the ISSNHL group and 9.1 per 1000 person-years in the comparison group. After adjustment for other factors, individuals with ISSNHL developed affective disorders more frequently than those in the comparison group (HR, 1.50; 95% CI, 1.30-1.75). Among the affective disorders, the HR of developing depression (HR, 1.66; 95% CI, 1.44-1.91) and anxiety disorder (HR, 1.79; 95% CI, 1.56-2.05) but not bipolar disorder (HR, 0.95; 95% CI, 0.54-1.70), was significantly greater in patients with ISSNHL.Conclusions and relevanceThis cohort study suggests that ISSNHL is associated with an increased incidence of affective disorders, specifically depression and anxiety. Therefore, these findings suggest that clinicians should monitor patients with ISSNHL carefully, and take specific precautions to reduce their risk of depression and anxiety disorder.

Dataset Information

Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial.

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