Clinical trial NCT04826237: Oral Statins and Protection From Hearing Loss
Official title: Towards a Self-Administered Hearing Protection Regimen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sudden Sensorineural Hearing Loss
Keywords: deafness
statin
hearing loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Pure Tone Audiometry for Hearing Assessment
timeFrame: At the initiation and the end of the study (up to 4 months after initial assessment)
measure: Change in Speech Discrimination
timeFrame: At the initiation and the end of the study, up to 4 months after initial assessment
measure: Change in Tinnitus Score
timeFrame: AT the initiation and the end of the study, up to 4 months after initial assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Donna Whitlon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: