Short-term Oral Steriods for Acute Tinnitus

Tinnitus, Subjective Clinical Trial

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: January 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 learn about the efficacy of oral steroids in the acute tinnitus population. Participants will receive appropriate dosages of prednisone and/or oral Ginkgo Biloba tablets.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• 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. primary complaint of subjective tinnitus = 3 months of duration;

3. a decline in auditory function by audiological assessments on the day of the test, of which a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results;

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).

Related Conditions & MeSH terms

• Hearing Loss
• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• Prednisone tablet
The dose selection of oral prednisone is the maximum daily dose for 5 days, followed by a taper every 2 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