Sudden Sensorineural Hearing LossPhase 4NCT04826237
Oral Statins and Protection From Hearing Loss
A Phase 4 study testing Statin, methylprednisolone and dexamethasone in people with Sudden Sensorineural Hearing Loss, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- Statin, methylprednisolone and dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 30 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
Who cannot join
- 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
Show all 29Show fewer
- 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 1 month
- 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 2 weeks
- Heart disease or TIAs
- Chronic kidney failure
- HIV, Hepatitis B or C
- Active shingles
- Skull, facial or temporal bone anomalies
- COVID-19 immunization within the last 30 days Patients that medically cannot be treated with corticosteroids or statins or that the physician feels have possible coexisting problems that would cause participation in the study to be unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Towards a Self-Administered Hearing Protection Regimen
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.
Read the 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.
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- Statin, methylprednisolone, dexamethasone, Placebo
- Keywords
- deafness, statin, hearing loss
- Medical subject headings
- Hearing Loss, Sudden, Deafness, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called HMG-coA reductase Inhibitor
Oral dose to be taken with methylprednisolone
Also called medrol
oral dose, standard of care
dexamethasoneDrug
Also called decadron
Drug for intratympanic administration
PlaceboDrug
Capsule the same as for statins but without statin
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | 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. Receives: Drug: Statin; Drug: methylprednisolone; Drug: dexamethasone |
| Placebo | Placebo comparator | 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. Receives: Drug: methylprednisolone; Drug: dexamethasone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Articulation Index
Estimates how much of normal conversational speech is audible to that ear. Max score is 100%, min score is 0%
Measured: 2 weeks, 4 weeks, 6 weeks
Word Recognition Score
Measures how many words you correctly repeat when speech is presented at an audible level.
- 90-100% = Excellent
- 80-89% = Good
- 70-79% = Fair
- Below 70% = Significant difficulty
Measured: 2 weeks, 4 weeks, 6 weeks
Tinnitus Handicap Inventory (THI)
Tinnitus Handicap Inventory (THI) is a scale which measures severity of tinnitus. Minimum score is 0 and maximum score is 100. A higher score indicates greater severity of symptoms. Additionally, the numerical scores are divided into the following grades:
Grade 1 (Slight): 0-16 Grade 2 (Mild): 18-36 Grade 3 (Moderate): 38-56 Grade 4 (Severe): 58-76 Grade 5 (Catastrophic): 78-100
Measured: 2 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Feb 2023
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Sensorineural Hearing LossStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Whitlon, Ph.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826237
- Sponsor's protocol ID
- STU00212929
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2021
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Only unidentified data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Self-Administered Hearing Protection Regimen
- ClinicalTrials.gov ID
- NCT04826237
- Acronym / sponsor ID
- STU00212929
- Conditions
- Sudden Sensorineural Hearing Loss
- Keywords
- deafness, statin, hearing loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 29 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: Statin, Drug: methylprednisolone, Drug: dexamethasoneMethylprednisolone+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. |
| Placebo | Placebo comparator | Drug: methylprednisolone, Drug: dexamethasone, Drug: PlaceboMethylprednisolone+ 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 30 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
Key exclusion criteria (29 listed)
- Children
- Prisoners
- Pregnant women
- Patients who have experienced similar prior events of SSNHL
- Patients with bacterial infections, mycoplasma, Lyme disease, tuberculosis, syphilis, fungal infections,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinAlso: HMG-coA reductase InhibitorOral dose to be taken with methylprednisolone | Drug | Statin |
| methylprednisoloneAlso: medroloral dose, standard of care | Drug | Placebo, Statin |
| dexamethasoneAlso: decadronDrug for intratympanic administration | Drug | Placebo, Statin |
| PlaceboCapsule the same as for statins but without statin | Drug | Placebo |
Primary outcome
Articulation Index
Time frame: 2 weeks, 4 weeks, 6 weeks
Estimates how much of normal conversational speech is audible to that ear. Max score is 100%, min score is 0%
Word Recognition Score
Time frame: 2 weeks, 4 weeks, 6 weeks
Measures how many words you correctly repeat when speech is presented at an audible level. * 90-100% = Excellent * 80-89% = Good * 70-79% = Fair * Below 70% = Significant difficulty
Tinnitus Handicap Inventory (THI)
Time frame: 2 weeks, 6 weeks
Tinnitus Handicap Inventory (THI) is a scale which measures severity of tinnitus. Minimum score is 0 and maximum score is 100. A higher score indicates greater severity of symptoms. Additionally, the numerical scores are divided into the following grades: Grade 1 (Slight): 0-16 Grade 2 (Mild): 18-36 Grade 3 (Moderate): 38-56 Grade 4 (Severe): 58-76 Grade 5 (Catastrophic): 78-100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only unidentified data will be shared
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Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Whitlon, Ph.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Statin, methylprednisolone and dexamethasone in people with Sudden Sensorineural Hearing Loss, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Articulation Index (time frame: 2 weeks, 4 weeks, 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.