Hydroxychloroquine added to steroids for sudden hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial randomizes adults with unilateral idiopathic SSNHL to receive either prednisolone alone or prednisolone plus hydroxychloroquine for about two months. The primary outcome is the change in pure-tone average hearing in the affected ear over 3 months. Secondary outcomes include the change in hearing in both ears. The study uses standard steroid therapy as the control and adds hydroxychloroquine in the experimental arm to see if it can enhance recovery and assess safety in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Kaohsiung Chang Gung Memorial Hospital
  Kaohsiung City, Taiwan Recruiting

Study contacts

• Principal investigator: Chao-Hui Yang — Chang Gung Memorial Hospital
• Study coordinator: Chao-Hui Yang, MD,PhD
• Email: chouwhay@gmail.com
• Phone: 88677317123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Yiyuancong treatment for sudden sensorineural hearing loss

  This trial will test whether adding Yiyuancong, a traditional Chinese medicine formula, to standard care helps adults with sudden sensorineural hearing loss recover more hearing.

  Recruiting at 5 sites Guangdong Provincial People's Hospital · Guangzhou, Guangdong and 4 other locations · NCT07505667

• Combining acupuncture with steroid therapy for sudden hearing loss

  This trial will test whether adding acupuncture to standard steroid treatment helps adults with sudden sensorineural hearing loss recover hearing.

  Recruiting China Medical University Hospital · Taichung · NCT07235488

• Cohort of patients with sudden sensorineural hearing loss

  This study is tracking patients with sudden hearing loss to see how well different treatments help them recover over time.

  Recruiting Wonju Severance Christian Hospital · Wŏnju, Gangwon-do · NCT05474963

• Exploring the effects of positive airway pressure on sudden hearing loss and sleep apnea

  This study is testing if using positive airway pressure therapy can help people with sudden hearing loss and sleep apnea feel better.

  Recruiting Phase 4 Beijing Tsinghua Chang Gung Hospital · Beijing, Beijing Municipality · NCT04192656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.