Different Dosing Regimens of STOP-AST

Hearing Loss Clinical Trial

Official title:

Comparing Two Dosing Regimens of the Efficacy of Short-term Oral Prednisone Therapy on Acute Subjective Tinnitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06124703
• Other study ID #: different STOP-AST regimens
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Shan Sun
• Phone: +86-18917786102
• Email: sunshine7896[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the different dose regimens of the efficacy of oral steroids in the acute tinnitus population. Participants will receive different appropriate dosages of prednisone tablets and oral Ginkgo Biloba tablets.

Description:

The purpose of this clinical study was to investigate the efficacy and to compare two different oral doses of short-term systemic steroid therapy for acute tinnitus.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: November 30, 2024
• Est. primary completion date: February 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 18-60 years old;

2. primary complaint of subjective tinnitus = 1 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 > 20 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. 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

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss
• Tinnitus

Intervention

Drug:
• Prednisone tablet
Prednisone acetate tablet (5 mg prednisone acetate per tablet) was provided
• Ginkgo Biloba Extract
Ginkgo biloba extract (EGb) is a compound drug derived from Ginkgo biloba trees native to China.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

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	one week 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	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	one month 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.	one week 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.	one month 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).	one week 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).	one month from baseline