The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects

The sense of gravity is one of the important input of our balance system. The utricle is the key structure on this subject but the contribution of the proprioceptive receptors is also important. The aim of this study is to measure the effect of different angles of head tilt and soft surface on SVV in healthy subjects with a new automated system.

Study Overview

• Status: Completed
• Conditions: Vestibular Nerve Diseases
• Intervention / Treatment: Diagnostic test: Subjective Visual Vertical with Virtual SVV instrument

Detailed Description

Two different settings will be used. In the first experiment, healthy subjects will make 15, 30, and 45-degree head tilt to the left and right side while they are standing. In every position, 3 measurements will be done. In the second experiment, 40 health subjects will make the same head maneuvers on the 20 cm thick soft surface. We will compare the effects of both head tilt and soft surface. All measurements will be done with a virtual SVV system(Interacoustics).

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No ear disease
• No neurologic disease
• No surgery for ear, brain or musculoskeletal system

Exclusion Criteria:

• Diabetes mellitus
• Drug use effective on central nervous system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Virtual SVV; The subjects will be tested by virtual SVV. The deviation angle will be measured at 15, 30 and 45-degree head tilt to the left and right side while they are standing	Diagnostic test: Subjective Visual Vertical with Virtual SVV instrument; The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Visual Vertical	The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing	1 month

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Fazıl N Ardıç, MD, Department of otolaryngology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): July 30, 2020

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): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 11, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Cranial Nerve Diseases; Retrocochlear Diseases; Nervous System Diseases; Vestibulocochlear Nerve Diseases
• Other Study ID Numbers: 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared from 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