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Short-term Oral Steriods for Acute Tinnitus

Primary Purpose

Tinnitus, Subjective, Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone tablet
Ginkgo Biloba Extract
Sponsored by
Eye & ENT Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus, Subjective

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-65 years old;
  2. primary complaint of non-pulsatile tinnitus ≤ 3 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 > 25 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. history of other obvious causes of tinnitus (such as otitis media, tympanic membrane perforation, external auditory canal inflammation);
  2. physical trauma to the ear immediately preceding tinnitus;
  3. both the PTA and DPOAE with normal outcomes;
  4. 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).

Sites / Locations

  • Eye and ENT Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prednisone plus placebo group

control group

Arm Description

a 10mg/d tapering 14-day course of oral prednisone intervention (the initial dose: 1mg/kg/day, max 60mg/day) in combination with ginkgo biloba agent (120mg daily)

Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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).
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).

Full Information

First Posted
October 16, 2022
Last Updated
August 31, 2023
Sponsor
Eye & ENT Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05591144
Brief Title
Short-term Oral Steriods for Acute Tinnitus
Official Title
Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
January 22, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus, Subjective, Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prednisone plus placebo group
Arm Type
Experimental
Arm Description
a 10mg/d tapering 14-day course of oral prednisone intervention (the initial dose: 1mg/kg/day, max 60mg/day) in combination with ginkgo biloba agent (120mg daily)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients took oral standardized Ginkgo biloba extracts (120 mg daily) three times a day.
Intervention Type
Drug
Intervention Name(s)
Prednisone tablet
Other Intervention Name(s)
prednisone
Intervention Description
The dose selection of oral prednisone is the maximum daily dose for 5 days, followed by a taper every 2 days
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract
Other Intervention Name(s)
ginkgo biloba
Intervention Description
Ginkgo biloba extracts are traditional Chinese medicine, which can improve microcirculation and provide good ameliorating effects for the treatment of tinnitus
Primary Outcome Measure Information:
Title
tinnitus handicap inventory (THI)
Description
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.
Time Frame
two weeks from baseline
Title
tinnitus handicap inventory (THI)
Description
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.
Time Frame
four weeks from baseline
Title
tinnitus handicap inventory (THI)
Description
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.
Time Frame
twelve weeks from baseline
Secondary Outcome Measure Information:
Title
visual analog scale (VAS)
Description
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Time Frame
two weeks from baseline
Title
visual analog scale (VAS)
Description
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Time Frame
four weeks from baseline
Title
visual analog scale (VAS)
Description
mark the severity of tinnitus on a horizontal scale from 0 to 10. The higher the score, the more severe the symptoms.
Time Frame
twelve weeks from baseline
Title
the Athens Insomnia Scale-8 (AIS-8)
Description
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).
Time Frame
two weeks from baseline
Title
the Athens Insomnia Scale-8 (AIS-8)
Description
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).
Time Frame
four weeks from baseline
Title
the Athens Insomnia Scale-8 (AIS-8)
Description
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).
Time Frame
twelve weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-65 years old; primary complaint of subjective tinnitus ≤ 3 months of duration; 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: a reduced distortion product otoacoustic emissions (DPOAE) amplitude in individuals with normal Pure tone audiometry (PTA) results; more than a PTA threshold > 20 dB with frequencies between 125 and 8000 Hz, but not exhibited idiopathic sudden sensorineural hearing loss; a state of good general condition; with good adherence to participation and signed informed consent. Exclusion Criteria: active middle ear pathology; patients who had received treatment for their current condition prior to the study; both the PTA and DPOAE with normal outcomes; hearing implants; 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shan Sun
Organizational Affiliation
Eye and ENT Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye and ENT Hospital of Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Short-term Oral Steriods for Acute Tinnitus

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