Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jun 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of hydroxychloroquine, a medication often used for other conditions, to see if it can help improve hearing recovery in patients with sudden sensorineural hearing loss (SSNHL). SSNHL is a condition where a person experiences a sudden loss of hearing, typically in one ear, and it can occur within a few days. The standard treatment for this condition is steroids, but results can vary from person to person. The trial will involve 80 participants who have received steroid treatment and will be divided into two groups: one group will receive hydroxychloroquine along with steroids, and the other group will receive steroids alone. The researchers will track changes in hearing over three months to understand if hydroxychloroquine makes a difference.

To join this trial, participants need to be between 18 and 70 years old and must have experienced significant hearing loss in one ear within three days. They should also be able to understand and follow the study instructions. However, there are some criteria that would exclude certain individuals, such as those who are pregnant, have certain types of ear problems or medical conditions, or are taking specific medications. The trial will monitor participants for potential side effects to ensure their safety. If you're considering participating, it could help researchers learn more about potential new treatments for sudden hearing loss.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Unilateral idiopathic sudden sensorineural hearing loss ≥ 30 dB in at least 3 consecutive frequencies, compared to the contralateral ear, within 3 days
• • 2. Enrollment has to be accomplished within 14 days after SSNHL onset
• • 3. Male or female aged ≥ 18 to 70 years
• • 4. Ability to understand and follow the study protocol
• Exclusion Criteria:
• • 1. Pregnant or breast-feeding female
• • 2. positive pregnancy test before receiving the study drug
• • 3. Due to a history of physical efforts suspected perilymph fistula or membrane rupture.
• • 4. Previously existing, known retrocochlear hearing loss
• • 5. Any history of any ear operation or chronic inflammatory disease of middle ear in the past one year
• • 6. History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.
• • 7. History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, and otosclerosis.
• • 8. History of chronic inflammatory diseases or autoimmune diseases
• • 9. Prior chemotherapy or treatment with immunosuppressant drugs
• • 10. Patients on renal dialysis
• • 11. Patients with history of retinopathy, or are using drugs that could induce retinopathy, such as Tamoxifen
• • 12. History of allergy to hydroxychloroquine
• • 13. Patients who are contraindicated with oral steroid treatment