The Effects of Chronic Otitis Surgery on SVV

September 14, 2023 updated by: Fazıl Necdet Ardıç, Pamukkale University

The Effects of Chronic Otitis Surgery on Virtual Subjective Vertical

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic otitis media

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery group
Subjects who will have chronic otitis media surgery will be included in the study.
Diagnostic test: Subjective Visual Vertical
All subjects will have Virtual SVV before and after the operation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Fazıl N Ardıç, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2020

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 17, 2020

First Submitted That Met QC Criteria

May 17, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be available in university depository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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