Sudden Hearing LossPhase 2NCT06467526
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
A Phase 2 study testing Hydroxychloroquine and Steroid in people with Sudden Hearing Loss, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sudden Hearing Loss
- What is being tested?
- Hydroxychloroquine and Steroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Sep 2024to 31 Mar 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Chao-Hui Yang, Chao-Hui, chouwhay@gmail.com
Chao-Hui, chouwhay@gmail.com
About this study
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.
Read the detailed description
Sudden sensorineural hearing loss (SSNHL) significantly affects a patient's 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.
- Experimental group: Treatment with oral prednisolone (5 mg) for 14 days (high dosage 1 mg/kg/day for 7 days and gradually taper in the next week) and hydroxychloroquine for 60 days (400 mg/day)
- Control group: Treatment with oral prednisolone (5 mg) for 14 days (high dosage 1 mg/kg/day for 7 days and gradually taper in the next week)
- 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 0.5k, 1k, 2k, and 4 kHz.
- Secondary endpoints:
- the change in PTA in the bilateral ear from screening until one week, two weeks, one month, and two months
- change in word recognition score (WRS) in the bilateral ear from screening to one week, two weeks, one month, two months and three months
- The grade of hearing recovery by Siegel's criteria from screening to 3 months
- Percentage of recovery from screening until 3 months
- change in bilateral tinnitus severity (evaluted by VAS and THI) from screening to one month, 2 months and 3 months
- Conditions
- Sudden Hearing Loss
- Being tested
- Hydroxychloroquine, Steroid
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hydroxychloroquine (400mg/day) for 2 months
SteroidDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine group | Experimental | Hydroxychloroquine with steroid Receives: Drug: Hydroxychloroquine; Drug: Steroid |
| Control group | Other | Steroid only Receives: Drug: Steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing improvement
To evaluate if hydroxychloroquine could increase the hearing improvement
Measured: from screening until 3 months
Secondary outcomes (2)
Word recognition score
To evaluate if hydroxychloroquine could increase the word recognition score
Measured: from screening until 3 months
Tinnitus severity
To evaluate if hydroxychloroquine could decrease the tinnitus severity
Measured: from screening until 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start10 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao-Hui Yang, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467526
- Sponsor's protocol ID
- CPRPG8P0011
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No