Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    218
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Send
Updated on 4 October 2022
See if I qualify

Summary

The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy

Details
Condition Hearing Loss, Sudden
Treatment Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
Clinical Study IdentifierNCT05455398
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years old, ≤ 65 years old
The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region
Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve inner ear circulation, but have not responded to treatment (PTA improvement < 15 dB)
No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy; no general anesthesia - contraindication
Patients voluntarily participate in this study and sign an informed consent form

Exclusion Criteria

Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, syndromic deafness malignant tumors
Pregnant and lactating women
Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction
Any other conditions that the investigator believes should be excluded from this study
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note