Ignite Creation Date:
2024-07-17 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467526
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-16
Brief Title:
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sudden sensorineural hearing loss SSNHL is diagnosed when theres a sudden drop in hearing of at least 30 decibels across three consecutive frequencies emerging within up to 72 hours In clinical settings steroids are the predominant treatment for SSNHL However the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially Moreover a systematic review of randomized clinical trials has found no conclusive evidence pinpointing an effective treatment for SSNHL Hydroxychloroquine a derivative of chloroquine is a medication that has gained attention for its potential role in modulating the immune response We aim to see if hydroxychloroquine could augment hearing recovery in SSNHL under steroid treatment and to evaluate the safety of hydroxychloroquine in the treatment of SSNHL patients We plan to enroll 80 SSNHL patients who received oral steroid therapy and randomize them into an experimental group hydroxychloroquine with prednisolone 40 patients and a control group prednisolone 40 patients The primary endpoint will be the change in pure tone audiogram PTA in the affected ear from screening until 3 months The secondary endpoints will be the change in word recognition score and the change in bilateral tinnitus severity after treatment Any side effects will be recorded to ensure the safety of this clinical trial
Detailed Description:
Sudden sensorineural hearing loss SSNHL significantly affects a patients social and interpersonal interactions It presents as an abrupt decrease in hearing usually within a matter of hours or days SSNHL typically impacts one ear and can range in severity sometimes resulting in total deafness In clinical settings steroids are the predominant treatment for SSNHL Yet the outcomes for patients undergoing steroid therapy for SSNHL can differ substantially Hydroxychloroquine a derivative of chloroquine is a medication that has gained attention for its potential role in modulating the immune response Our study hypothesized that hydroxychloroquine could help the hearing recovery during the steroid treatment for SSNHL
In this project we will enroll two groups of subjects for our study
1 Experimental group Treatment with oral prednisolone 5 mg for 14 days high dosage 1 mgkgday for 7 days and gradually taper in the next week and hydroxychloroquine for 60 days 400 mgday
2 Control group Treatment with oral prednisolone 5 mg for 14 days high dosage 1 mgkgday for 7 days and gradually taper in the next week
A Primary endpoint
The primary outcome measure for this study is the change in pure tone audiogram PTA in the affected ear from screening until 3 months The PTA will be calculated as the arithmetic mean of air conduction thresholds at the frequency of 05k 1k 2k and 4 kHz
B Secondary endpoints
1 the change in PTA in the bilateral ear from screening until one week two weeks one month and two months
2 change in word recognition score WRS in the bilateral ear from screening to one week two weeks one month two months and three months
3 The grade of hearing recovery by Siegels criteria from screening to 3 months
4 Percentage of recovery from screening until 3 months
5 change in bilateral tinnitus severity evaluted by VAS and THI from screening to one month 2 months and 3 months
In this project we will enroll two groups of subjects for our study
1 Experimental group Treatment with oral prednisolone 5 mg for 14 days high dosage 1 mgkgday for 7 days and gradually taper in the next week and hydroxychloroquine for 60 days 400 mgday
2 Control group Treatment with oral prednisolone 5 mg for 14 days high dosage 1 mgkgday for 7 days and gradually taper in the next week
A Primary endpoint
The primary outcome measure for this study is the change in pure tone audiogram PTA in the affected ear from screening until 3 months The PTA will be calculated as the arithmetic mean of air conduction thresholds at the frequency of 05k 1k 2k and 4 kHz
B Secondary endpoints
1 the change in PTA in the bilateral ear from screening until one week two weeks one month and two months
2 change in word recognition score WRS in the bilateral ear from screening to one week two weeks one month two months and three months
3 The grade of hearing recovery by Siegels criteria from screening to 3 months
4 Percentage of recovery from screening until 3 months
5 change in bilateral tinnitus severity evaluted by VAS and THI from screening to one month 2 months and 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None