Oral Statins and Protection From Hearing Loss

Sudden Sensorineural Hearing Loss Clinical Trial

Official title:

Towards a Self-Administered Hearing Protection Regimen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826237
• Other study ID #: STU00212929
• Status: Recruiting
• Phase: Phase 4
• Start date: February 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Donna Whitlon, Ph.D.
• Phone: 8479229047
• Email: whitlon[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sudden Sensorineural Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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