The Effect of Patient's Position After Intra-tympanic Injection
May 8, 2020 updated by: Tel-Aviv Sourasky Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
Description
Inclusion Criteria:
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
- Patients who signed an informed consent form
Exclusion Criteria:
- Dysgeusia
- Inner or middle ear malfomation
- Eustachian tube dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients seated after Intra-Tympanic injection
|
Seating position after Intra Tympanic injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
0 Minutes, and then 10, 20, 30 minutes after the injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2020
Primary Completion (ANTICIPATED)
June 30, 2021
Study Completion (ANTICIPATED)
June 30, 2021
Study Registration Dates
First Submitted
May 8, 2020
First Submitted That Met QC Criteria
May 8, 2020
First Posted (ACTUAL)
May 12, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2020
Last Update Submitted That Met QC Criteria
May 8, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0182-20-TLVMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.