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Oral Statins and Protection From Hearing Loss

Primary Purpose

Sudden Sensorineural Hearing Loss

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Statin
methylprednisolone
dexamethasone
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sudden Sensorineural Hearing Loss focused on measuring deafness, statin, hearing loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Statin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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)

Secondary Outcome Measures

Full Information

First Posted
February 24, 2021
Last Updated
February 8, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04826237
Brief Title
Oral Statins and Protection From Hearing Loss
Official Title
Towards a Self-Administered Hearing Protection Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Sensorineural Hearing Loss
Keywords
deafness, statin, hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes 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
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Statin
Other Intervention Name(s)
HMG-coA reductase Inhibitor
Intervention Description
Oral dose to be taken with methylprednisolone
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
medrol
Intervention Description
oral dose, standard of care
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
Drug for intratympanic administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule the same as for statins but without statin
Primary Outcome Measure Information:
Title
Change in Pure Tone Audiometry for Hearing Assessment
Description
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.
Time Frame
At the initiation and the end of the study (up to 4 months after initial assessment)
Title
Change in Speech Discrimination
Description
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.
Time Frame
At the initiation and the end of the study, up to 4 months after initial assessment
Title
Change in Tinnitus Score
Description
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)
Time Frame
AT the initiation and the end of the study, up to 4 months after initial assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donna Whitlon, Ph.D.
Phone
8479229047
Email
whitlon@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Whitlon, Ph.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only unidentified data will be shared

Learn more about this trial

Oral Statins and Protection From Hearing Loss

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