Oral Statins for Hearing Loss
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Northwestern University
Must be taking: Oral steroids
Must not be taking: Ototoxic medications, Statins, Antidepressants, others
Disqualifiers: Diabetes, Heart disease, Psychiatric syndromes, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used statins in the last 12 months or have had oral steroid treatment in the last 30 days. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug for hearing loss?
Research shows that dexamethasone, when administered directly into the ear, can help prevent the worsening of hearing loss in conditions like Ménière's disease, with some patients even experiencing improvement. This suggests that steroids like dexamethasone may have potential in treating hearing loss.12345
How is the drug used in the Oral Statins for Hearing Loss trial different from other treatments for hearing loss?
The treatment in the trial uses oral steroids like dexamethasone and methylprednisolone, which are typically used for their anti-inflammatory effects, and this approach is unique because it explores the potential of these drugs to protect hearing by reducing inflammation, unlike traditional treatments that may not focus on inflammation control.14678
Research Team
DW
Donna Whitlon, Ph.D.
Principal Investigator
Northwestern University
Eligibility Criteria
Adults aged 18-80 with sudden one-sided hearing loss, diagnosed within the first two weeks of symptoms. Participants must have a significant level of hearing loss and be fluent in English. Excluded are those with prior similar events, certain diseases (like diabetes or severe neurological conditions), history of substance abuse, recent steroid use, ear anomalies, or who've taken statins or ototoxic drugs recently.Inclusion Criteria
Your average hearing loss is 30 decibels or more across three specific frequencies.
I speak and understand English very well.
Seen in the clinic within the first 14 days after the onset of symptoms
See 2 more
Exclusion Criteria
You are allergic or sensitive to any parts of the study medication.
I have taken statins in the past year.
I have a genetic condition that affects my hearing.
See 25 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive oral methylprednisolone and either a statin or placebo for 7 days, with potential intratympanic dexamethasone if no improvement after 2 weeks
4 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including hearing tests and tinnitus evaluation
up to 4 months
2 visits (in-person)
Treatment Details
Interventions
- dexamethasone (Drug)
- methylprednisolone (Drug)
- Placebo (Drug)
- Statin (HMG-CoA Reductase Inhibitor)
Trial OverviewThe trial is testing if adding an oral statin to standard treatment for sudden sensorineural hearing loss improves outcomes. Standard treatment includes methylprednisolone and intratympanic dexamethasone as salvage therapy. Hearing improvement and tinnitus will be measured.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: StatinExperimental Treatment3 Interventions
Methylprednisolone+statin (identity and dose to be determined before Trial Begins) Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day;
Oral statin 1 dose per day for 7 days, beginning with the first dose of methylprednisolone:
If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
Group II: PlaceboPlacebo Group3 Interventions
Methylprednisolone+ placebo. Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral placebo 1 dose per day for 7 days, beginning with the first dose of methylprednisolone
If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
dexamethasone is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Decadron for:
- Allergic reactions
- Blood diseases
- Eye diseases
- Skin diseases
- Respiratory diseases
- Rheumatic diseases
- Gastrointestinal diseases
🇪🇺 Approved in European Union as Dexamethasone for:
- Cerebral edema
- Acute asthma
- Chronic obstructive pulmonary disease (COPD)
- Allergic reactions
- Skin diseases
- Eye diseases
🇨🇦 Approved in Canada as Dexamethasone for:
- Allergic reactions
- Blood diseases
- Eye diseases
- Skin diseases
- Respiratory diseases
- Rheumatic diseases
🇯🇵 Approved in Japan as Dexamethasone for:
- Cerebral edema
- Acute asthma
- Chronic obstructive pulmonary disease (COPD)
- Allergic reactions
- Skin diseases
- Eye diseases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern Memorial HospitalChicago, IL
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Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Trials
1674
Patients Recruited
989,000+
References
Open trial of methotrexate as treatment for autoimmune hearing loss. [2022]To assess the efficacy of low-dose methotrexate (MTX) administered for the treatment of autoimmune hearing loss.
Topical ocular drug delivery to inner ear disease and sinusitis. [2014]Oral steroids are the main therapy for sensorineural deafness. We present the rare case of a patient whose hearing loss associated with inflammation of the inner ear and chronic sinusitis were improved with topical steroid therapy. A 68-year-old male presented with scleritis in the left eye, inflammation of the inner ear and chronic sinusitis. He received oral prednisolone 10 mg/d. However, the oral prednisolone was discontinued due to severe side effects. Topical administration of 0.1% betamethasone sodium phosphate improved the scleritis and incidentally also relieved his symptoms of recurrent otitis and sinusitis after several days. Audiometry revealed recovered acoustic sensation in the right ear, from 50 dB to 20 dB, and in the left ear from 70 to 35 dB with 1,000 Hz. Topical ocular drug delivery of steroids may be effective for inner ear disease and sinusitis in patients with systemic side effects to oral steroids.
Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial. [2022]To evaluate in patients with idiopathic sensorineural hearing loss whether pulse therapy with methylprednisolone leads to better recovery of hearing than traditional oral prednisolone therapy.
Biopolymer-released dexamethasone prevents tumor necrosis factor alpha-induced loss of auditory hair cells in vitro: implications toward the development of a drug-eluting cochlear implant electrode array. [2013]Polymer-eluted dexamethasone (DXM) will retain its ability to protect against tumor necrosis factor alpha (TNFalpha)-induced hair cell (HC) loss.
Intratympanically administered steroid for progressive sensorineural hearing loss in Ménière's disease. [2020]Background: Ménière's disease is characterised by episodic rotational vertigo, sensorineural hearing loss, tinnitus, and vegetative symptoms. Objectives: The aim of our study is to follow-up the effects of the intratympanic steroid treatment of hearing loss in MD. Material and methods: A group of 105 clinically diagnosed MD patients were enrolled in this investigation. Long-term follow-up was carried out, and pure tone speech audiometry results of the subjects before and after application of steroid were contrasted. Statistical analysis was carried out using the IBM SPSS V24 software. Results: Based on the audiograms in this population, all stages of hearing loss were presented (from slight to profound). In most of the cases (68.6%), after intratympanic dexamethasone treatment, stagnation in the hearing profile was achieved. Moreover, there was a smaller group demonstrating hearing improvement after the treatment (12.4%). According to logistic regression [p = .001; Odds ratio: 2.75 (95% CI 1.068-4.442,)], there was a strong correlation between hearing improvement and dexamethasone treatment (all patients were treated with intratympanic dexamethasone, while improvement without steroid treatment could never be attained). Conclusions and significance: Intratympanically administered dexamethasone is a potent agent to prevent the progression of hearing loss in MD.
Cochlear implant surgery facilitates intracochlear distribution of perioperative systemic steroids. [2023]Systemically administered steroids are widely utilised for hearing preservation therapies. More recently, steroids have been administered to achieve hearing protection after cochlear implant surgery. Currently there is a lack of understanding as to which administration route offers most therapeutic efficacy, local or systemic administration. Paramount to this are observations in animal studies that systemic administration following implantation offers hearing protection and reduced cochlear fibrosis, despite observations that perilymphatic levels are up to 10-fold higher after local administration in non-implanted cochleae.
The Clinical Effect of Steroid Therapy on Preserving Residual Hearing after Cochlear Implantation with the Advanced Bionics HiRes Ultra 3D Cochlear Implant System. [2022](1) Background: The main aim of this study was to assess the clinical effectiveness of two different schemes of administration of steroids ((1) dexamethasone administered intravenously in comparison with (2) combination of steroid treatments: orally administered prednisone and intravenously administered dexamethasone) in comparison with a control group (no steroid administration) on hearing preservation (HP) in patients who underwent an Advanced Bionics cochlear implantation. (2) Methods: Thirty-five adult patients met the inclusion criteria. All patients were randomly divided into three subgroups depending on the scheme of steroid administration: (1) the first subgroup with only intravenously administered dexamethasone (0.1 mg per kg body weight twice a day for three days), (2) the second subgroup with a combination of methods of administration of steroids (intravenous and oral steroid therapy (dexamethasone, 0.1 mg/kg body weight twice a day plus prednisone, 1 mg/kg weight once a day for three days before surgery and after administration of dexamethasone (4th, 5th, 6th day) and after this time the dose of prednisone was reduced)) and (3) the third subgroup without steroid therapy (control group). The results were measured by pure tone audiometry (PTA) in three periods: (1) before implantation, (2) during activation of the processor (one month after implantation), and (3) 12 months after activation. Patients' hearing thresholds before implantation were on average 82 dB HL, 77 dB HL, and 88 dB HL, respectively. (3) Results: The majority of the patients from the first subgroup had hearing preserved partially (77.8%). A similar result was observed in the second study group (oral + i.v.) (partial hearing preservation was found in 61.5% of the participants). The opposite was true in the control group; a plurality of control patients (38.5%) had no measurable hearing 12 months after the activation of the processor. (4) Conclusions: Pharmacological treatment consisting of the administration of steroids in patients who had undergone cochlear implantation with the Advanced Bionics HiRes Ultra 3D cochlear implant system may be beneficial for preserving residual hearing in patients.
Glucocorticoids inhibit diastrophic dysplasia sulfate transporter activity in otosclerosis by interleukin-6. [2018]Otosclerosis is a bone remodeling disorder localized to the otic capsule and associated with inflammation. In vitro, increased activity of the diastrophic dysplasia sulfate transporter (DTDST), which is implicated in bone metabolism, has been reported. Because glucocorticoids modulate the bone turnover and inhibit inflammatory processes, we investigated the effect of dexamethasone (Dex) on interleukin-6 and DTDST in otosclerosis.