Different Dosing Regimens of STOP-AST

Not Applicable

Not yet recruiting

• Conditions: Tinnitus; Hearing Loss; Sensorineural Hearing Loss
• Interventions: Drug: Prednisone tablet; Drug: Ginkgo Biloba Extract

• Registration Number: NCT06124703
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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 of prednisone tablets and oral Ginkgo Biloba tablets.

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-05
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-09
• Study Start: 2023-11-10
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-02-10
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no taper regimen	Prednisone tablet	The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days
dose-tapering regimen	Prednisone tablet	The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days
dose-tapering regimen	Ginkgo Biloba Extract	The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days
no taper regimen	Ginkgo Biloba Extract	The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days

Primary Outcome Measures

Name	Time	Method
tinnitus handicap inventory (THI)	one month from baseline	The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus

Secondary Outcome Measures

Name	Time	Method
visual analog scale (VAS)	one month from baseline	mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
the Athens Insomnia Scale-8 (AIS-8)	one month from baseline	The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24).