Sudden Hearing LossNCT04449848
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
A study testing Sitting after intra tympanic injection in people with Sudden Hearing Loss, run by Tel-Aviv Sourasky Medical Center.
Trial summary
During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Hearing Loss
- What is being tested?
- Sitting after intra tympanic injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear
Who cannot join
- Patients with abnormal sense of taste
- Middle or inner ear anomaly
- Eustachian tube dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.
- Conditions
- Sudden Hearing Loss
- Being tested
- Sitting after intra tympanic 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.
Sitting after intra tympanic injectionOther
Sitting after intra tympanic injection
| Study group | Role | What they receive |
|---|---|---|
| Sitting after intra tympanic injection | Experimental | Patients with Sudden hearing loss sitting after intra tympanic injection of steroids Receives: Other: Sitting after intra tympanic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bitter taste
Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449848
- Sponsor's protocol ID
- 0182-20
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
- ClinicalTrials.gov ID
- NCT04449848
- Acronym / sponsor ID
- 0182-20
- Conditions
- Sudden Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 29 Jun 2020 (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.
During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sitting after intra tympanic injection | Experimental | Other: Sitting after intra tympanic injectionPatients with Sudden hearing loss sitting after intra tympanic injection of steroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear
Key exclusion criteria (3 listed)
- Patients with abnormal sense of taste
- Middle or inner ear anomaly
- Eustachian tube dysfunction
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 |
|---|---|---|
| Sitting after intra tympanic injectionSitting after intra tympanic injection | Other | Sitting after intra tympanic injection |
Primary outcome
Bitter taste
Time frame: 30 minutes
Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
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Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
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Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
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Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
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Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting after intra tympanic injection in people with Sudden Hearing Loss, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 3 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 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Yahav Oron, MD (+97236973573, oron.yahav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bitter taste (time frame: 30 minutes). 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 29 Jun 2020.