NCT04224909

Brief Summary

The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

January 8, 2020

Last Update Submit

January 8, 2020

Conditions

Sudden Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • The gain of each canal, as calculated using the vHIT

    Gain measured by the vHIT system

    15 minutes

Study Arms (1)

Patients with Sudden Sensorineural Hearing Loss

Diagnostic Test: Video Head Impulse Test

Interventions

Video Head Impulse TestDIAGNOSTIC_TEST

Diagnosis of dysfunction of the semicircular canals using the vHIT

Patients with Sudden Sensorineural Hearing Loss

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

You may qualify if:

  • Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss

You may not qualify if:

  • Vertigo
  • Other etiology causing dizziness
  • Neurological dysfunction othe than the hearing loss
  • Difficulty performing the vHIT
  • Chronic vestibular disorder
  • Pregnant women

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

036973573yahavo@tlvmc.gov.il

Study Design

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

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

February 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share