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Oral Statins for Hearing Loss
Study Summary
This trialwill test if adding a statin to standard ISSNHL treatment can improve hearing, speech, and tinnitus. Patients will be monitored to measure results.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You are allergic or sensitive to any parts of the study medication.I have taken statins in the past year.I have a genetic condition that affects my hearing.I currently have shingles.I do not have any current infections like bacterial, Lyme disease, tuberculosis, or fungal.I have a tumor-related condition like neurofibromatosis II.I do not have severe epilepsy, Parkinson's, dementia/Alzheimer's, or multiple sclerosis.I have a mitochondrial disorder such as MELAS or Cogan's syndrome.I have been diagnosed with hyperviscosity syndrome.I have been diagnosed with sarcoidosis.I have taken oral steroids in the last 30 days.I have heart disease or have had TIAs.I have middle ear inflammation or fluid buildup.I am not taking any medication known to affect hearing.I have had a head injury or lead poisoning.I have chronic kidney failure.I do not have HIV, Hepatitis B, or Hepatitis C.You have had tinnitus in the past.I have had ear surgery, but not just for ear tubes.Your average hearing loss is 30 decibels or more across three specific frequencies.I speak and understand English very well.I am a child.I have an autoimmune disease affecting my ears.I have had sudden hearing loss before.I have diabetes.You have had problems with drugs or alcohol in the past two years.I am currently being treated for a psychiatric condition with medication.I have abnormalities in my skull or face bones.I am between 19 and 80 years old.I was diagnosed with sudden hearing loss in one ear.I have sudden hearing loss in one ear, confirmed by tests.
- Group 1: Statin
- Group 2: Placebo
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research study extend to individuals older than fifty years of age?
"Per the parameters of this trial, only persons between 18 and 80 years old can be considered for enrollment."
Who meets the criteria for enrollment in this clinical study?
"In order to gain admittance into this trial, candidates must have recently experienced hearing loss and be between the ages of 18-80. Approximately 100 individuals are being sought after for participation."
Are recruitment efforts currently underway for this clinical trial?
"According to the information provided on clinicaltrials.gov, enrollment for this study is underway as of now. The trial was initially published online in February 9th 2023 and has been updated most recently on February 8th 2023."
To what condition is Statin typically prescribed?
"Statin is frequently administered to treat synovitis but can also be helpful in managing ophthalmia, sympathetic disorders, scalp structure issues and branch retinal vein occlusions."
What is the capacity of this clinical trial in terms of participants?
"Affirmative. According to information from clinicaltrials.gov, this experiment commenced on February 9th 2023 and is still actively seeking out volunteers; the study requires a total of 100 participants from one single medical centre."
Has the US Food and Drug Administration sanctioned the use of Statin?
"The safety of statin is backed by Phase 4 approval, thus it has been assigned a score of 3 on our team's scale."
Have previous research projects focused on Statin?
"Presently, there are 639 clinical trials in progress for Statin with 167 of those being at the Phase 3 level. Although many studies take place in Duarte, California, a total of 22049 different medical centres worldwide have conducted research involving this drug."
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