Oral Statins and Protection From Hearing Loss

Towards a Self-Administered Hearing Protection Regimen

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.

Study Overview

• Status: Recruiting
• Conditions: Sudden Sensorineural Hearing Loss
• Intervention / Treatment: Drug: Statin; Drug: methylprednisolone; Drug: dexamethasone; Drug: Placebo

Detailed Description

After being informed about the study and potential risks, all patients diagnosed with idopathic sudden sensorineural hearing loss who do not meet the exclusion criteria and do meet the inclusion criteria, and who give written informed consent will be enrolled in the trial. A standard treatment for ISSNHL (oral methyprednisolone) will be given to half of the patients and the other half of the patients will receive the standard treatment plus either a placebo or a 7-day course of an HMG-CoA reductase inhibitor (a statin). Patients will return for follow up, the timing and further treatment of which will be determined by the response to the drugs. At each appointment, the patients will see the medical professional, have a hearing test, a speech in noise test, and self evaluate for tinnitus. If there is no improvement after 2 weeks, patient will be offered up to two intratympanic doses of dexamethasone, 10 days apart. This is a randomized, double-blind prospective study. Randomization of males will be separate from that of females.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Donna Whitlon, Ph.D.; Phone Number: 8479229047; Email: whitlon@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient older than 18 years and younger than 81 years and
• Diagnosed with one sided idiopathic sudden sensorineural hearing loss by physical examination, history, audiology, speech interpretation tests and tinnitus evaluation and
• Seen in the clinic within the first 14 days after the onset of symptoms. and
• Mean hearing threshold equal to or worse than >30 dB averaged across three consecutive frequencies.
• Excellent English Speaking and Comprehension

Exclusion Criteria:

• Children
• Prisoners
• Pregnant women
• Patients who have experienced similar prior events of SSNHL
• Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections,
• Autoimmune inner ear disease
• Middle ear inflammation or effusion
• Ototoxic medication such as chemotherapy, loop diuretics, high dose aspirin, etc.
• Head Trauma, lead poisoning
• Genetic disorders affecting hearing
• Mitochondrial disorders, including MELAS (metabolic encephalopathy, lactic acidosis, and stroke-like episodes), stroke, Cogan's syndrome
• Neoplastic (neurofibromatosis II, bilateral vestibular schwannomas, carcinomatous meningitis, intravascular lymphomatosis, others)
• Sarcoidosis
• Hyperviscosity syndrome
• Diabetes
• Use of statins within the last 12 months
• Allergy, hypersensitivity or intolerance to any components of the study medication
• Prior tinnitus
• Prior otologic surgery other than ventilation tubes
• History of drug abuse or alcoholism within the prior 2 years
• Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics
• Severe systemic neurologic disease (epilepsy, Parkinson's, dementia/Alzheimers, multiple sclerosis
• Oral steroid treatment within the preceding 30 days
• Heart disease or TIAs
• Chronic kidney failure
• HIV, Hepatitis B or C
• Active shingles
• Skull, facial or temporal bone anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Statin; 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.	Drug: Statin; Oral dose to be taken with methylprednisolone; Other Names: HMG-coA reductase Inhibitor; Drug: methylprednisolone; oral dose, standard of care; Other Names: medrol; Drug: dexamethasone; Drug for intratympanic administration; Other Names: decadron
Placebo Comparator: Placebo; 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.	Drug: methylprednisolone; oral dose, standard of care; Other Names: medrol; Drug: dexamethasone; Drug for intratympanic administration; Other Names: decadron; Drug: Placebo; Capsule the same as for statins but without statin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pure Tone Audiometry for Hearing Assessment	Pure tone audiometry to calculate Pure tone averages (PTA) at 500 Hz, 1 kHz, 2 kHZ and 4 kHz. will be measured before and at the end of the study. PTA within 15 dB of the pretreatment PTA of the contralateral cochlea will be considered complete improvement. At the end of the study, PTA improvement will be compared between experimental and placebo groups, with a difference of 15 dB or more considered a change in response. PTA at the end of the study will also be compared between a) males and female groups; b)compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; c) PTA will also be determined and compared between different age groups. PTA at the end of the study together with word recognition scores at the end of the study will be used to determine the class of hearing improvement using the Gardner-Robertson Scale.	At the initiation and the end of the study (up to 4 months after initial assessment)
Change in Speech Discrimination	At the beginning and the end of the study, word recognition improvement will be compared a) between experimental and placebo groups;b) between males and female groups; c) compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; d) word recognition scores will also be and compared between different age groups. At the end of the study, Word recognition score (% correct). will be used with the PTA at the end of the study to to calculate the Gardner-Robertson classification of hearing improvement.	At the initiation and the end of the study, up to 4 months after initial assessment
Change in Tinnitus Score	Tinnitus Handicap Index; A 6 point or better change in the index indicates improvement. AT the end of the study, Tinnitus Index improvement (change) will be compared a) between experimental and placebo groups; b) between males and female groups c); compared between those presenting for treatment within 1 week of loss of hearing and those presenting between 1 week and 2 weeks; and d)	AT the initiation and the end of the study, up to 4 months after initial assessment

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Donna Whitlon, Ph.D., Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: hearing loss; statin; deafness
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Antimetabolites; Protective Agents; Neuroprotective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Methylprednisolone Acetate; Dexamethasone; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: STU00212929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only unidentified data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes