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Oral Statins for Hearing Loss

Phase 4
Recruiting
Led By Donna Whitlon, Ph.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Excellent English Speaking and Comprehension
Patient older than 18 years and younger than 81 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the initiation and the end of the study, up to 4 months after initial assessment
Awards & highlights

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.

Who is the study for?
Adults aged 18-80 with sudden one-sided hearing loss, diagnosed within the first two weeks of symptoms. Participants must have a significant level of hearing loss and be fluent in English. Excluded are those with prior similar events, certain diseases (like diabetes or severe neurological conditions), history of substance abuse, recent steroid use, ear anomalies, or who've taken statins or ototoxic drugs recently.Check my eligibility
What is being tested?
The trial is testing if adding an oral statin to standard treatment for sudden sensorineural hearing loss improves outcomes. Standard treatment includes methylprednisolone and intratympanic dexamethasone as salvage therapy. Hearing improvement and tinnitus will be measured.See study design
What are the potential side effects?
Possible side effects include muscle pain, headaches, nausea from statins; weight gain, mood swings from methylprednisolone; and brief pain or dizziness from dexamethasone injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I speak and understand English very well.
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I am between 19 and 80 years old.
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I was diagnosed with sudden hearing loss in one ear.
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I have sudden hearing loss in one ear, confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the initiation and the end of the study (up to 4 months after initial assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the initiation and the end of the study (up to 4 months after initial assessment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pure Tone Audiometry for Hearing Assessment
Change in Speech Discrimination
Body Weight Changes

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: StatinExperimental Treatment3 Interventions
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.
Group II: PlaceboPlacebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Statin
2011
Completed Phase 4
~110100
methylprednisolone
2004
Completed Phase 4
~1050
dexamethasone
1995
Completed Phase 3
~9860

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,685 Total Patients Enrolled
Donna Whitlon, Ph.D.Principal InvestigatorNorthwestern University

Media Library

dexamethasone Clinical Trial Eligibility Overview. Trial Name: NCT04826237 — Phase 4
Sudden Hearing Loss Research Study Groups: Statin, Placebo
Sudden Hearing Loss Clinical Trial 2023: dexamethasone Highlights & Side Effects. Trial Name: NCT04826237 — Phase 4
dexamethasone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04826237 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern Memorial Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I have not tried anything and would like to see if something works. I told my doctor about my symptoms but nothing was done,.
PatientReceived no prior treatments
~32 spots leftby Oct 2024