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NCT04449848 Clinical Trial

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

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 NCT04449848
Other study ID # 0182-20
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2021

Study information
Verified date June 2020
Source Tel-Aviv Sourasky Medical Center
Contact Yahav Oron, MD
Phone +97236973573
Email oron.yahav@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date July 31, 2021
Est. primary completion date July 31, 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 to the middle ear

Exclusion Criteria:

- Patients with abnormal sense of taste

- Middle or inner ear anomaly

- Eustachian tube dysfunction

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Sitting after intra tympanic injection
Sitting 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 Bitter taste Bitter taste described by the patients using a questionnaire with a scale of 0 to 5 30 minutes
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 NCT06467526 - Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss Phase 2
Not yet recruiting NCT04384640 - The Effect of Patient's Position After Intra-tympanic Injection