The Effects of Chronic Otitis Surgery on SVV | NCT04396145

Studies
The Effects of Chronic Otitis Surgery on SVV

NCT04396145

Sponsor

Pamukkale University

Status

Active, not recruiting

Last Update Posted

Dec 27, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Chronic Otitis Media

Interventions

Subjective Visual Vertical

Countries

Turkey (Türkiye)

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2020Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

May 17, 2020

First Submission Date that Met QC Criteria

May 17, 2020

First Posted Date

May 20, 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

Dec 24, 2024

Last Update Posted Date

Dec 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Inner ear trauma during chronic otitis surgery is one of the major concerns of Otolaryngology. Hearing thresholds or semicircular canals were investigated with this purpose. The investigator's aim is to test the utricle for surgical trauma.

Detailed Description

All patients who will have surgery for ear will be tested before the operation and after the first day and the first week. Virtual SVV(Interacoustics) will be used for testing. The deviation angle from the vertical line will be measured when 15, 30, and 45-degree head tilt to the left and right side while they were standing.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery group		Subjects who will have chronic otitis media surgery will be included in the study.	Diagnostic Test: Subjective Visual Vertical

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subjective Visual Vertical	Diagnostic Test	All subjects will have Virtual SVV before and after the operation	Surgery group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SVV angle	Right and Left deviation angle when head tilted 15, 30, and 45 degree	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic Otitis Media
Who had surgical treatment

Exclusion Criteria:

A patient who had the vestibular disease before
Neurologic disease
Patients who had ear, brain and musculoskeletal surgery before

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic otitis media

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fazıl N Ardıç	Pamukkale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University		Denizli	Denizli	20070	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

The data will be available in university depository

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided