NCT04449848

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 24, 2020

Last Update Submit

June 26, 2020

Conditions

Sudden Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Bitter taste

    Bitter taste described by the patients using a questionnaire with a scale of 0 to 5

    30 minutes

Study Arms (1)

Sitting after intra tympanic injection

EXPERIMENTAL

Patients with Sudden hearing loss sitting after intra tympanic injection of steroids

Other: Sitting after intra tympanic injection

Interventions

Sitting after intra tympanic injectionOTHER

Sitting after intra tympanic injection

Sitting after intra tympanic injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear

You may not qualify if:

  • Patients with abnormal sense of taste
  • Middle or inner ear anomaly
  • Eustachian tube dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Sudden

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yahav Oron, MD

CONTACT

+97236973573oron.yahav@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2020

First Posted

June 29, 2020

Study Start

August 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share