Short-term Oral Prednisone for Acute Subjective Tinnitus

Tinnitus, Subjective Clinical Trial

— STOP-FAST  

Official title:

Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591144
• Other study ID #: STOP for AST
• Status: Completed
• Phase: N/A
• Start date: October 30, 2022
• Est. completion date: February 3, 2024

Study information

• Verified date: May 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to investigate the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of short-term prednisone and/or oral Ginkgo Biloba tablets.

Description:

Researchers will compare the intervention group and placebo-control group to see whether short-term systemic steroid therapy is effective for acute tinnitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: February 3, 2024
• Est. primary completion date: January 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18-65 years old;

2. a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;

3. a definition of normal hearing in line with the World Report on Hearing (2021), of which the average value of hearing threshold at 500, 1000, 2000, 4000 Hz in better ear was less than 20 decibels;

4. a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;

5. a state of good general condition.

Exclusion Criteria:

1. had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;

2. had received treatment for their current condition before the study;

3. taken oral steroids within 3 months before randomization;

4. had hearing implants;

5. had participated in other clinical trials and have not terminated the trials;

6. had a history of known corticosteroid contraindications (including osteoporosis, peptic ulcers, poorly controlled hypertension, diabetes, chronic liver or renal insufficiency, tumorous condition, alcohol abuse, pregnancy, or taking estrogen-containing oral contraceptive steroids);

7. auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Prednisone tablet
The dose selection of oral prednisone is the maximum daily dose based on weight for 4 days, followed by a taper every 2 days, with the maximum duration to 14 days.
• Ginkgo Biloba Extract
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus

Locations

Country	Name	City	State
China	Eye and ENT Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	four weeks from baseline
Primary	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.	twelve weeks from baseline
Secondary	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
Secondary	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.	four weeks from baseline
Secondary	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.	twelve weeks from baseline
Secondary	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
Secondary	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).	four weeks from baseline
Secondary	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).	twelve weeks from baseline