Back to resultsThe Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Primary Purpose
Vestibular Nerve Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Subjective Visual Vertical with Virtual SVV instrument
Sponsored by
About this trial
This is an interventional other trial for Vestibular Nerve Diseases
Eligibility Criteria
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual SVV
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04396132
Brief Title
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Official Title
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Nerve Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual SVV
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Subjective Visual Vertical with Virtual SVV instrument
Intervention Description
The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing
Primary Outcome Measure Information:
Title
Subjective Visual Vertical
Description
The measurement of deviation angle with 15, 30 and 45-degree head tilt to the left and right side while they are standing
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fazıl N Ardıç, MD
Organizational Affiliation
Department Of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared from university depository
Learn more about this trial
The Effect of Head Tilt and Soft Surface on Virtual SVV in Normal Subjects
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