Status:
UNKNOWN
Different Dosing Regimens of STOP-AST
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Hearing Loss
Tinnitus
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages...
Detailed Description
The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.
Eligibility Criteria
Inclusion
- 18-60 years old;
- primary complaint of subjective tinnitus ≤ 1 months of duration;
- a decline in auditory function by audiological assessments on the day of the test, of which the outcome must either satisfy one of the following conditions:
- a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
- more than a PTA threshold \> 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
- a state of good general condition;
- with good adherence to participation and signed informed consent.
Exclusion
- active middle ear pathology;
- patients who had received treatment for their current condition prior to the study;
- both the PTA and DPOAE with normal outcomes;
- hearing implants;
- history of known corticosteroids contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnant patients, and women on estrogen-containing oral contraceptive steroids).
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06124703
Start Date
November 10 2023
End Date
November 30 2024
Last Update
November 13 2023
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