NCT04384640

Brief 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.

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 all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

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

May 8, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 8, 2020

Last Update Submit

May 8, 2020

Conditions

Sudden Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients seated after Intra-Tympanic injection

Other: Change of posture after Intra Tympanic injection

Interventions

Change of posture after Intra Tympanic injectionOTHER

Seating position after Intra Tympanic injection

Patients seated after Intra-Tympanic injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids

You may qualify if:

  • Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids
  • Patients who signed an informed consent form

You may not qualify if:

  • Dysgeusia
  • Inner or middle ear malfomation
  • 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

CONTACT

0523523181oron.yahav@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 12, 2020

Study Start

July 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 12, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share