Different Dosing Regimens of STOP-AST

Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss; Sensorineural Hearing Loss; Tinnitus
• Intervention / Treatment: Drug: Prednisone tablet; Drug: Ginkgo Biloba Extract

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 Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peifan Li; Phone Number: +86-18373151369; Email: 20211260020@fudan.edu.cn
• Study Contact Backup: Name: Shan Sun; Phone Number: +86-18917786102; Email: sunshine7896@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dose-tapering regimen; The dose selection of oral prednisone is the maximum daily dose for 4 days, followed by a taper every 2 days	Drug: Prednisone tablet; Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided; Other Names: Prednisone; Drug: Ginkgo Biloba Extract; Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.; Other Names: EGb
Experimental: no taper regimen; The dose selection of oral prednisone is the maximum daily dose, applied for 5 consecutive days	Drug: Prednisone tablet; Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided; Other Names: Prednisone; Drug: Ginkgo Biloba Extract; Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.; Other Names: EGb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tinnitus handicap inventory (THI)	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	one week from baseline
tinnitus handicap inventory (THI)	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	two weeks from baseline
tinnitus handicap inventory (THI)	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	one month from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS)	mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.	one week from baseline
visual analog scale (VAS)	mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.	one month from baseline
the Athens Insomnia Scale-8 (AIS-8)	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).	one week from baseline
visual analog scale (VAS)	mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.	two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)	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).	two weeks from baseline
the Athens Insomnia Scale-8 (AIS-8)	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).	one month from baseline

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University
• Investigators: Principal Investigator: Shan Sun, Eye and ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): February 10, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Estimated): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Tinnitus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: different STOP-AST regimens

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No