Back to resultsThe Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Primary Purpose
Sudden Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sitting after intra tympanic injection
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear
Exclusion Criteria:
- Patients with abnormal sense of taste
- Middle or inner ear anomaly
- Eustachian tube dysfunction
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sitting after intra tympanic injection
Arm Description
Patients with Sudden hearing loss sitting after intra tympanic injection of steroids
Outcomes
Primary Outcome Measures
Bitter taste
Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
Secondary Outcome Measures
Full Information
NCT ID
NCT04449848
First Posted
June 24, 2020
Last Updated
June 26, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04449848
Brief Title
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Official Title
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitting after intra tympanic injection
Arm Type
Experimental
Arm Description
Patients with Sudden hearing loss sitting after intra tympanic injection of steroids
Intervention Type
Other
Intervention Name(s)
Sitting after intra tympanic injection
Intervention Description
Sitting after intra tympanic injection
Primary Outcome Measure Information:
Title
Bitter taste
Description
Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear
Exclusion Criteria:
Patients with abnormal sense of taste
Middle or inner ear anomaly
Eustachian tube dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahav Oron, MD
Phone
+97236973573
Email
oron.yahav@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
We'll reach out to this number within 24 hrs