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To Investigate the Effect in Patients with Severe Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) Treated by Different doses of Intratympanic Dexamethasone (ITD)

To Investigate the Effect in Patients with Severe Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) Treated by Different doses of Intratympanic Dexamethasone (ITD)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058824
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden hearing loss

Interventions

A:intratympanic dexamethasone by 5mg/ml
B:intratympanic dexamethasone by 10 mg/ml
C:intratympanic dexamethasone by 15 mg/ml

Sponsors

Eye & ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to AAO-HNS diagnostic criteria diagnosed as sudden deafness(Diagnostic criteria: sudden onset of unexplained sensorineural hearing loss within 72 hours, >=30dB of hearing loss at least three adjacent frequencies in 500, 1K, 2K, 4K, and 8K Hz.); 2. Any gender, ages 18 to 70 years; 3. Within 2 weeks of sudden onset of SSNHL; 4. Severe hearing loss: the average of pure tone hearing threshold >60dB(hearing loss on the day of enrollment); 5. Unilateral SSNHL; 6. Sign the informed consent and voluntary.

Exclusion criteria

Exclusion criteria: 1. There are known and clear causes of sudden deafness; 2. Previous history of Meniere's disease and hearing loss; 3. Prior to the onset of hearing abnormalities and balance dysfunction; 4. Pregnant and lactating women; 5. Taking or nearly 3 months may affect the symptoms characterization of drugs; 6. Patients complicated with other diseases, such as otitis media, severe cervical vertebra disease, fracture, etc., and unable to complete the examination items; 7. Patients with severe organ dysfunction; 8. Severe hypertension, more than 160/100mmHg; 9. Contraindications to hyperbaric oxygen, such as glaucoma, pulmonary bronchiectasis and myopia greater than 1000 degree; 10. Contraindications of hormones such as gastric ulcer, systemic fungal infection, liver function damage, hypothyroidism, renal function damage and tuberculosis; 11. Combined allergy on hormone or enlarge vascular drug, etc; 12. Patients participating in other drug or device clinical trials that did not meet the primary study endpoint.

Design outcomes

Primary

MeasureTime frame
Pure tone audiometry;

Countries

China

Contacts

Public ContactJing Wang

Eye & ENT Hospital, Fudan University

jingwang615@126.com+86 18917786267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026