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Completed

NCT Number: NCT05591144

Short-term Oral Prednisone for Acute Subjective Tinnitus

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.

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and ENT Hospital of Fudan University

Shanghai, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old;
  • a primary complaint of frequent occurrences of subjective tinnitus lasting at least 5 minutes within the past 3 months ;
  • 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;
  • a score of more than 16 points on the Tinnitus Handicap Inventory (THI), which indicates that the level of tinnitus exceeds mild severity;
  • a state of good general condition.

Exclusion criteria

  • had previous history of middle ear pathology, apparent history of noise exposure, noise trauma or head injury;
  • had received treatment for their current condition before the study;
  • taken oral steroids within 3 months before randomization;
  • had hearing implants;
  • had participated in other clinical trials and have not terminated the trials;
  • 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);
  • auditory hallucinations or other conditions deemed inappropriate for inclusion by the investigator.

Treatment and study plan

Prednisone tablet

Drug

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.

Other names: prednisone

Ginkgo biloba extract

Drug

Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus

Other names: ginkgo biloba

Primary outcomes

  1. tinnitus handicap inventory (THI)

    Time frame: two weeks 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.

  2. tinnitus handicap inventory (THI)

    Time frame: four weeks 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.

  3. tinnitus handicap inventory (THI)

    Time frame: twelve weeks 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 outcomes

  1. visual analog scale (VAS)

    Time frame: two weeks from baseline

    The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.

  2. visual analog scale (VAS)

    Time frame: four weeks from baseline

    The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.

  3. visual analog scale (VAS)

    Time frame: twelve weeks from baseline

    The subjective perception of tinnitus loudness will be evaluated using a Visual Analog Scale (VAS). Participants will be instructed to rate the perceived loudness of their tinnitus on a scale ranging from 0, indicating "no loudness," to 10, representing "maximum imaginable loudness." Higher scores on this scale will correspond to greater perceived loudness of tinnitus symptoms.

  4. the Athens Insomnia Scale-8 (AIS-8)

    Time frame: two weeks 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).

  5. the Athens Insomnia Scale-8 (AIS-8)

    Time frame: four weeks 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).

  6. the Athens Insomnia Scale-8 (AIS-8)

    Time frame: twelve weeks 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).

Sponsors and collaborators

Lead sponsor

Eye & ENT Hospital of Fudan University

Other

Registry information

Official study title

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

Acronym: STOP-FAST

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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