The Effect of Patient's Position After Intra-tympanic Injection

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: Sudden Hearing Loss
• Intervention / Treatment: Other: Change of posture after Intra Tympanic injection

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients seated after Intra-Tympanic injection	Other: Change of posture 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	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

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

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: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sudden
• 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