Video HIT in Sudden Sensorineural Hearing Loss | NCT04224909

Studies
Video HIT in Sudden Sensorineural Hearing Loss

NCT04224909

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jan 13, 2020Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Sudden Sensorineural Hearing Loss

Interventions

Video Head Impulse Test

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2020Estimated

Primary Completion Date

Jan 31, 2021Estimated

Completion Date

Jan 31, 2021Estimated

First Submitted Date

Jan 8, 2020

First Submission Date that Met QC Criteria

Jan 8, 2020

First Posted Date

Jan 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2020

Last Update Posted Date

Jan 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Sudden Sensorineural Hearing Loss			Diagnostic Test: Video Head Impulse Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video Head Impulse Test	Diagnostic Test	Diagnosis of dysfunction of the semicircular canals using the vHIT	Patients with Sudden Sensorineural Hearing Loss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The gain of each canal, as calculated using the vHIT	Gain measured by the vHIT system	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with Sudden Sensorineural Hearing Loss

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yahav Oron, MD	Contact	036973573		yahavo@tlvmc.gov.il

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003639	Hearing Loss, Sudden

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided