Clinical trial NCT05591144: Short-term Oral Prednisone for Acute Subjective Tinnitus
Official title: Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus, Subjective
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: tinnitus handicap inventory (THI)
timeFrame: two weeks from baseline
measure: tinnitus handicap inventory (THI)
timeFrame: four weeks from baseline
measure: tinnitus handicap inventory (THI)
timeFrame: twelve weeks from baseline
Secondary outcomes:
measure: visual analog scale (VAS)
timeFrame: two weeks from baseline
measure: visual analog scale (VAS)
timeFrame: four weeks from baseline
measure: visual analog scale (VAS)
timeFrame: twelve weeks from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: two weeks from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: four weeks from baseline
measure: the Athens Insomnia Scale-8 (AIS-8)
timeFrame: twelve weeks from baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Shan Sun
role: PRINCIPAL_INVESTIGATOR
References: