NCT04826237

Oral Statins and Protection From Hearing Loss

Towards a Self-Administered Hearing Protection Regimen

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Statin	Oral dose to be taken with methylprednisolone
DRUG	methylprednisolone	oral dose, standard of care
DRUG	dexamethasone	Drug for intratympanic administration
DRUG	Placebo	Capsule the same as for statins but without statin

Timeline

• Start date: 2023-02-09
• Primary completion: 2025-10-01
• Completion: 2025-12-31
• First posted: 2021-04-01
• Last updated: 2024-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study