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NCT04384640 Clinical Trial

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

Sudden Hearing Loss Clinical Trial

Official title:
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04384640
Other study ID # 0182-20-TLVMC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date June 30, 2021

Study information
Verified date May 2020
Source Tel-Aviv Sourasky Medical Center
Contact ?Yahav Oron
Phone 0523523181
Email oron.yahav@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). The patients will be asked if they taste the steroids in their throats.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Change of posture after Intra Tympanic injection
Seating position after Intra Tympanic injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04601909 - FX-322 in Adults With Age-Related Sensorineural Hearing Loss Phase 1
Completed NCT05086276 - FX-322 in Adults With Acquired Sensorineural Hearing Loss Phase 2
Completed NCT04629664 - FX-322 in Adults With Severe Sensorineural Hearing Loss Phase 1
Completed NCT03747874 - OSA and Sudden Sensorineural Hearing Loss N/A
Recruiting NCT04192656 - The Effect of PAP on ISSHL Comorbided With OSA Phase 4
Not yet recruiting NCT03706183 - Ischemia- Modified Albumin Levels in the Sudden Hearing Loss
Completed NCT03951584 - Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
Completed NCT04902963 - What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube? N/A
Not yet recruiting NCT03974867 - Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids N/A
Not yet recruiting NCT04449848 - The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear N/A