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Oral Statins and Protection From Hearing Loss

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ClinicalTrials.gov Identifier: NCT04826237
Recruitment Status : Not yet recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Donna S Whitlon, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Sudden Sensorineural Hearing Loss Drug: Statin Drug: methylprednisolone Drug: dexamethasone Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Neither the participant, the medical professionals, nor those that initially calculate the testing data will know which patient has the placebo or which has the statin. Each patient will be identified by number and sex. Only the clinical coordinator who records the names and treatments and the principal investigator (who does not see patients) will have access to the key. The drugs will be randomized in two groups (for female and male). No one doing data analysis will have any identifiable information other than sex and when the code is broken, the data will be tagged with the identification number of hte patient
Primary Purpose: Treatment
Official Title: Towards a Self-Administered Hearing Protection Regimen
Estimated Study Start Date : May 15, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: 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.

Drug: Statin
Oral dose to be taken with methylprednisolone
Other Name: HMG-coA reductase Inhibitor

Drug: methylprednisolone
oral dose, standard of care
Other Name: medrol

Drug: dexamethasone
Drug for intratympanic administration
Other Name: decadron

Placebo Comparator: 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.

Drug: methylprednisolone
oral dose, standard of care
Other Name: medrol

Drug: dexamethasone
Drug for intratympanic administration
Other Name: decadron

Drug: Placebo
Capsule the same as for statins but without statin




Primary Outcome Measures :
  1. Change in Pure Tone Audiometry for Hearing Assessment [ Time Frame: At the initiation and the end of the study (up to 4 months after initial 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.


  2. Change in Speech Discrimination [ Time Frame: At the initiation and the end of the study, up to 4 months after initial assessment ]

    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.


  3. Change in Tinnitus Score [ Time Frame: AT the initiation and the end of the study, up to 4 months after initial assessment ]

    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)




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Donna S Whitlon, Research Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04826237    
Other Study ID Numbers: STU00212929
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only unidentified data will be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Donna S Whitlon, Northwestern University:
deafness
statin
hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents