Hearing Loss, SuddenNCT05455398
Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss
A study testing Surgical treatment of round window niche enlargement via round window for inner ear drug delivery and Drum chamber drug injection in people with Hearing Loss, Sudden, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hearing Loss, Sudden
- What is being tested?
- Surgical treatment of round window niche enlargement via round window for inner ear drug delivery and Drum chamber drug injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510030
Yu Si, doctor, 16620081695, siyu5@mail.sysu.edu.cn
About this study
Official title: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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
- Conditions
- Hearing Loss, Sudden
- Being tested
- Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
- 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.
Surgical treatment of round window niche enlargement via round window for inner ear drug deliveryProcedure or surgery
The round window niche is surgically removed and the hormone is slowly released into the inner ear using a gelatin sponge that has absorbed the hormone in the round window
Drum chamber drug injectionProcedure or surgery
Injection of drugs into the tympanic chamber through the tympanic membrane
| Study group | Role | What they receive |
|---|---|---|
| Round window niche enlargement group | Experimental | The round window niche was surgically removed by general anesthesia, the round window membrane was opened as entirely as possible, and the blockage of the round window membrane was carefully identified. Receives: Procedure: Surgical treatment of round window niche enlargement via round window for inner ear drug delivery |
| Drum chamber injection group | Active comparator | Methylprednisolone (40 mg) was injected via puncture in the posterior quadrant of the tympanic membrane once daily for 7 d. Patients were instructed to remain supine for 30 min to keep the drug in the tympanic chamber and to avoid swallowing to prevent drug flow from the eustachian tube. Receives: Procedure: Drum chamber drug injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
Assessment of post-operative hearing improvement by pure tone audiometry
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Apr 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SuddenStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhigang ZHANG, master, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455398
- Sponsor's protocol ID
- SYS-Q-202106
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- ClinicalTrials.gov ID
- NCT05455398
- Acronym / sponsor ID
- SYS-Q-202106
- Conditions
- Hearing Loss, Sudden
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Round window niche enlargement group | Experimental | Procedure: Surgical treatment of round window niche enlargement via round window for inner ear drug deliveryThe round window niche was surgically removed by general anesthesia, the round window membrane was opened as entirely as possible, and the blockage of the round window membrane was carefully identified. |
| Drum chamber injection group | Active comparator | Procedure: Drum chamber drug injectionMethylprednisolone (40 mg) was injected via puncture in the posterior quadrant of the tympanic membrane once daily for 7 d. Patients were instructed to remain supine for 30 min to keep the drug in the tympanic chamber and to avoid swallowing to prevent drug flow from the eustachian tube. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical treatment of round window niche enlargement via round window for inner ear drug deliveryThe round window niche is surgically removed and the hormone is slowly released into the inner ear using a gelatin sponge that has absorbed the hormone in the round window | Procedure or surgery | Round window niche enlargement group |
| Drum chamber drug injectionInjection of drugs into the tympanic chamber through the tympanic membrane | Procedure or surgery | Drum chamber injection group |
Primary outcome
Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
Time frame: up to one year
Assessment of post-operative hearing improvement by pure tone audiometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhigang ZHANG, master study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of round window niche enlargement via round window for inner ear drug delivery and Drum chamber drug injection in people with Hearing Loss, Sudden, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu SI, doctor (16620081695, siyu5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.