Tinnitus, Subjective Clinical Trial
Official title:
Investigating the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus
Verified date | January 2024 |
Source | Eye & ENT Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
China | Eye and ENT Hospital of Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University |
China,
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 |
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