Oral Statins and Protection From Hearing Loss

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04826237

Collaborator

(none)

100

Enrollment

Arms

17.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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 Names: HMG-coA reductase Inhibitor Drug: methylprednisolone oral dose, standard of care Other Names: medrol Drug: dexamethasone Drug for intratympanic administration Other Names: 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 Names: medrol Drug: dexamethasone Drug for intratympanic administration Other Names: decadron Drug: Placebo Capsule the same as for statins but without statin

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 Names:

HMG-coA reductase Inhibitor

Drug: methylprednisolone

oral dose, standard of care

Other Names:

medrol

Drug: dexamethasone

Drug for intratympanic administration

Other Names:

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 Names:

medrol

Drug: dexamethasone

Drug for intratympanic administration

Other Names:

decadron

Drug: Placebo

Capsule the same as for statins but without statin

Outcome Measures

Primary Outcome Measures

Change in Pure Tone Audiometry for Hearing Assessment [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.
Change in Speech Discrimination [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.
Change in Tinnitus Score [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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