The Effect of Head Tilt and Soft Surface on Virtual SVV i... | NCT04396132

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

NCT04396132

Sponsor

Pamukkale University

Status

Completed

Last Update Posted

Jun 14, 2022Actual

Enrollment

118Actual

Phase

Not Applicable

Conditions

Vestibular Nerve Diseases

Interventions

Subjective Visual Vertical with Virtual SVV instrument

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2020Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jul 30, 2020Actual

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

Jun 11, 2022

Last Update Posted Date

Jun 14, 2022Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual SVV	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subjective Visual Vertical with Virtual SVV instrument	Diagnostic Test	The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fazıl N Ardıç, MD	Department Of Otolaryngology	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be shared from university depository

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000160	Vestibulocochlear Nerve Diseases

Ancestor Terms

ID	Term
D012181	Retrocochlear Diseases
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D003389	Cranial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided