Sudden Hearing LossNCT04384640
The Effect of Patient's Position After Intra-tympanic Injection
An observational study of Sudden Hearing Loss, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). 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?
- Change of posture after Intra Tympanic injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
Who may be able to join
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
- Patients who signed an informed consent form
Who cannot join
- Dysgeusia
- Inner or middle ear malfomation
- Eustachian tube dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.
- Conditions
- Sudden Hearing Loss
- Being tested
- Change of posture 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.
Change of posture after Intra Tympanic injectionOther
Seating position after Intra Tympanic injection
| Study group | Role | What they receive |
|---|---|---|
| Patients seated after Intra-Tympanic injection | Not described Receives: Other: Change of posture after Intra Tympanic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of taste
The patients will rate the degree of change of taste in their throat
Measured: 0 Minutes, and then 10, 20, 30 minutes after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- NCT04384640
- Sponsor's protocol ID
- 0182-20-TLVMC
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 12 May 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 12 May 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
- NCT04384640
- Acronym / sponsor ID
- 0182-20-TLVMC
- Conditions
- Sudden Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 12 May 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.
The effect of the patient's head on the leakage of steroids from the middle ear to the throat will be studied. The patients will be seated after one of the intra tympanic injections that are routonely performed due to Sudden Sensorineural Hearin Loss (SNHL). The patients will be asked if they taste the steroids in their throats.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients seated after Intra-Tympanic injection | – | Other: Change of posture after Intra Tympanic injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
Key inclusion criteria (2 listed)
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
- Patients who signed an informed consent form
Key exclusion criteria (3 listed)
- Dysgeusia
- Inner or middle ear malfomation
- 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 |
|---|---|---|
| Change of posture after Intra Tympanic injectionSeating position after Intra Tympanic injection | Other | Patients seated after Intra-Tympanic injection |
Primary outcome
Degree of taste
Time frame: 0 Minutes, and then 10, 20, 30 minutes after the injection
The patients will rate the degree of change of taste in their throat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: No
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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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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?
An observational study of 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 2 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 12 May 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 (0523523181, oron.yahav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of taste (time frame: 0 Minutes, and then 10, 20, 30 minutes after the injection). 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 12 May 2020.