Oral Statins and Protection From Hearing Loss

NCT04826237 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STU00212929
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sudden Sensorineural Hearing Loss

Keywords

deafness; statin; hearing loss

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Statin

EXPERIMENTAL

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; Drug: methylprednisolone; Drug: dexamethasone

Placebo

PLACEBO COMPARATOR

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; Drug: dexamethasone; Drug: Placebo

Interventions

Statin DRUG

Oral dose to be taken with methylprednisolone

Also known as: HMG-coA reductase Inhibitor

Statin

methylprednisolone DRUG

oral dose, standard of care

Also known as: medrol

Placebo; Statin

dexamethasone DRUG

Drug for intratympanic administration

Also known as: decadron

Placebo; Statin

Placebo DRUG

Capsule the same as for statins but without statin

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden; Deafness; Hearing Loss

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Methylprednisolone; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Donna Whitlon, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Whitlon, Ph.D.

CONTACT

8479229047; whitlon@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Neither the participant, the medical professionals, nor those that initially calculate the testing data will know which patient has the placebo or which has the statin. Each patient will be identified by number and sex. Only the clinical coordinator who records the names and treatments and the principal investigator (who does not see patients) will have access to the key. The drugs will be randomized in two groups (for female and male). No one doing data analysis will have any identifiable information other than sex and when the code is broken, the data will be tagged with the identification number of hte patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: April 1, 2021
• Study Start: February 9, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)