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NCT04826237 · ClinicalTrials.gov registry record · Phase 4
Oral Statins and Protection From Hearing Loss
A Phase 4 study of Sudden Sensorineural Hearing Loss, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04826237: Recruiting Phase 4 study of Sudden Sensorineural Hearing Loss, sponsored by Northwestern University.
NCT04826237 is a Phase 4 study of Sudden Sensorineural Hearing Loss that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04826237, a Phase 4 study of Sudden Sensorineural Hearing Loss, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 fe
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Statin
- DRUG methylprednisolone
- DRUG dexamethasone
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-02-09 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
What NCT04826237 shows while recruiting
NCT04826237 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Sudden Sensorineural Hearing Loss appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04826237 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04826237 about?
NCT04826237 is a clinical study titled "Oral Statins and Protection From Hearing Loss". 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 com...
What is the current status of trial NCT04826237?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2023-02-09. Estimated completion is 2025-12-31.
What conditions does trial NCT04826237 study?
This clinical trial studies the following conditions: Sudden Sensorineural Hearing Loss.
What interventions are being tested in trial NCT04826237?
The interventions under investigation include: Placebo (DRUG), Statin (DRUG), methylprednisolone (DRUG), dexamethasone (DRUG).
Who is sponsoring clinical trial NCT04826237?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04826237 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04826237's enrollment target sits among peer trials
100 770th of 2000 higher than 1,149 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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