The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04449848
Collaborator
(none)
20
1
12
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear
Anticipated Study Start Date
:
Aug 1, 2020
Anticipated Primary Completion Date
:
Jul 31, 2021
Anticipated Study Completion Date
:
Jul 31, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sitting after intra tympanic injection Patients with Sudden hearing loss sitting after intra tympanic injection of steroids |
Other: Sitting after intra tympanic injection
Sitting after intra tympanic injection
|
Outcome Measures
Primary Outcome Measures
- Bitter taste [30 minutes]
Bitter taste described by the patients using a questionnaire with a scale of 0 to 5
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tel-Aviv Sourasky Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT04449848
Other Study ID Numbers:
- 0182-20
First Posted:
Jun 29, 2020
Last Update Posted:
Jun 29, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: