Different Dosing Regimens of STOP-AST

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Nov 5, 2023

Keywords

ClinConnect Summary

The STOP-AST clinical trial is exploring how different doses of oral steroids, specifically prednisone, can help people who are experiencing recent tinnitus, which is a ringing or buzzing sound in the ears. Participants will also receive Ginkgo Biloba, a natural supplement often used for ear health. The study aims to find out which dosing regimen works best for improving hearing and reducing tinnitus symptoms.

To be eligible for this trial, participants should be between 18 and 60 years old and have been experiencing tinnitus for one month or less. They should also show signs of hearing loss based on specific hearing tests. It’s important to note that individuals with certain medical conditions or those who have received prior treatments for tinnitus will not be able to participate. If you join the trial, you can expect regular check-ins and assessments to monitor your progress. This study is not yet recruiting, so it’s a good idea to keep an eye out for updates if you or someone you know is interested in participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-60 years old;
• • 2. primary complaint of subjective tinnitus ≤ 1 months of duration;
• 3. 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:
• • 1. a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;
• • 2. more than a PTA threshold \> 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss;
• • 4. a state of good general condition;
• • 5. with good adherence to participation and signed informed consent.
• Exclusion Criteria:
• • 1. active middle ear pathology;
• • 2. patients who had received treatment for their current condition prior to the study;
• • 3. both the PTA and DPOAE with normal outcomes;
• • 4. hearing implants;
• • 5. 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).