RECRUITING

Oral Statins and Protection From Hearing Loss

Conditions

Sudden Sensorineural Hearing Loss deafness statin hearing loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Towards a Self-Administered Hearing Protection Regimen

Quick Facts

Study Start:2023-02-09

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04826237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Donna Whitlon, Ph.D.

CONTACT

8479229047

whitlon@northwestern.edu

Principal Investigator

Donna Whitlon, Ph.D.

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

Donna Whitlon, Ph.D., PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-09

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-02-09

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

deafness
statin
hearing loss

Additional Relevant MeSH Terms

Sudden Sensorineural Hearing Loss