Oral Statins and Protection From Hearing Loss

NCT ID: NCT04826237

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Sudden Sensorineural Hearing Loss

Keywords

deafness; statin; hearing loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Statin

Intervention Type: DRUG

Oral dose to be taken with methylprednisolone

methylprednisolone

Intervention Type: DRUG

oral dose, standard of care

dexamethasone

Intervention Type: DRUG

Drug for intratympanic administration

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.

Group Type: PLACEBO_COMPARATOR

methylprednisolone

Intervention Type: DRUG

oral dose, standard of care

dexamethasone

Intervention Type: DRUG

Drug for intratympanic administration

Placebo

Intervention Type: DRUG

Capsule the same as for statins but without statin

Interventions

Statin

Oral dose to be taken with methylprednisolone

Intervention Type: DRUG

methylprednisolone

oral dose, standard of care

Intervention Type: DRUG

dexamethasone

Drug for intratympanic administration

Intervention Type: DRUG

Placebo

Capsule the same as for statins but without statin

Intervention Type: DRUG

Other Intervention Names

HMG-coA reductase Inhibitor; medrol; decadron

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Donna S Whitlon

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna Whitlon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Donna Whitlon, Ph.D.

Role: CONTACT

Phone: 8479229047

Email: whitlon@northwestern.edu

Other Identifiers

STU00212929

Identifier Type: -

Identifier Source: org_study_id