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

NCT06467526 | Not Yet Recruiting Phase 2

• 1 other identifier: CPRPG8P0011
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sudden sensorineural hearing loss (SSNHL) is diagnosed when there's 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.

Conditions

Sudden Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Hearing improvement

  To evaluate if hydroxychloroquine could increase the hearing improvement

  from screening until 3 months

Secondary Outcomes (2)

• Word recognition score

  from screening until 3 months

• Tinnitus severity

  from screening until 3 months

Study Arms (2)

Hydroxychloroquine group

EXPERIMENTAL

Hydroxychloroquine with steroid

Drug: Hydroxychloroquine; Drug: Steroid

Control group

OTHER

Steroid only

Drug: Steroid

Interventions

Hydroxychloroquine DRUG

Oral hydroxychloroquine (400mg/day) for 2 months

Hydroxychloroquine group

Steroid DRUG

Oral prednisolone (5 mg) for 2 weeks (1 mg/kg/day for one week with gradually taper for another week with or without intratympanic dexamethasone 5 mg/ml injection for 2-4 times)

Control group; Hydroxychloroquine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral idiopathic sudden sensorineural hearing loss ≥ 30 dB in at least 3 consecutive frequencies, compared to the contralateral ear, within 3 days
• Enrollment has to be accomplished within 14 days after SSNHL onset
• Male or female aged ≥ 18 to 70 years
• Ability to understand and follow the study protocol

You may not qualify if:

• Pregnant or breast-feeding female
• positive pregnancy test before receiving the study drug
• Due to a history of physical efforts suspected perilymph fistula or membrane rupture.
• Previously existing, known retrocochlear hearing loss
• Any history of any ear operation or chronic inflammatory disease of middle ear in the past one year
• History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.
• History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops, and otosclerosis.
• History of chronic inflammatory diseases or autoimmune diseases
• Prior chemotherapy or treatment with immunosuppressant drugs
• Patients on renal dialysis
• Patients with history of retinopathy, or are using drugs that could induce retinopathy, such as Tamoxifen
• History of allergy to hydroxychloroquine
• Patients who are contraindicated with oral steroid treatment

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Hydroxychloroquine; Steroids

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Chao-Hui Yang

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hui Yang, MD,PhD

CONTACT

88677317123; chouwhay@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share