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The Use of Virtual Reality for the Treatment of Visual Vertigo.

Primary Purpose

Treatment of Visual Vertigo

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual environment with fast moving objects
Virtual environment with no movement
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Visual Vertigo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Those who have been diagnosed with visual vertigo and have scored a significant level on the Situational Characteristic Questionnaire (over 0.74 as per Pavlou et al., 2006).

Exclusion Criteria:

  • Those with or under investigation for epilepsy.
  • Those who have been determined to have no or limited balance function in both ears.
  • Those with reduced visual acuity that will leave them unable to view the 3D effects of the head mounted display.
  • Those with severe mental health disorders e.g. psychosis, paranoid disorders, bipolar disorder or a history of substance abuse.
  • Severe neck pain/ restricted movement.
  • Previous treatment for visual vertigo.
  • Those with an fluctuating vestibular disorder such as Ménière's disease or vestibular migraine.
  • Those with untreated Benign Paroxymal Positional Vertigo (BPPV).
  • Those with a significant brain injury, or head injury that results in a central vestibular disorder.
  • Those with an arrhythmia.

Sites / Locations

  • Royal Hallamshire HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group

Control group

Arm Description

Virtual environment with fast moving objects these are graded in intensity from 1-7. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.

Virtual environment with no movement graded at grade 0. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.

Outcomes

Primary Outcome Measures

Change in scoring on the Situational Characteristic Questionnaire
A measure of visual vertigo symptom level

Secondary Outcome Measures

Change in scoring on the PHQ-9 Questionnaire from week one to six
A measure of depression symptom level
Change in scoring on the GAD-7 Questionnaire from week one to six
A measure of anxiety symptom level

Full Information

First Posted
January 11, 2017
Last Updated
April 12, 2018
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT03020654
Brief Title
The Use of Virtual Reality for the Treatment of Visual Vertigo.
Official Title
The Use of Virtual Reality for the Treatment of Visual Vertigo.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the use of virtual environments presented on a head mounted display for the rehabilitation of those suffering with visual vertigo. The control group and treatment groups will be presented with two different sets of environments and be given the same head and eye exercises to complete within the environment. They will also be provided with at home exercises to complete.
Detailed Description
Visual vertigo occurs after the balance system suffers damage (e.g after a viral infection such as labyrinthitis). This causes an over-reliance on the eyes to maintain balance which causes disorientation in busy environments such as the supermarket. The treatment involves trying to desensitise the individual to visually stimulating situations. Further head and eye exercises are completed alongside the exposure to overcome the damage done to the balance system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Visual Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Virtual environment with fast moving objects these are graded in intensity from 1-7. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Virtual environment with no movement graded at grade 0. Participants complete head and eye exercises within the environment using focus points such as benches and lanterns for a six week treatment program.
Intervention Type
Other
Intervention Name(s)
Virtual environment with fast moving objects
Intervention Description
A beach/park environment with graded moving objects, the individual will complete head and eye exercises.
Intervention Type
Other
Intervention Name(s)
Virtual environment with no movement
Intervention Description
A beach/park environment with static objects, the individual will complete head and eye exercises.
Primary Outcome Measure Information:
Title
Change in scoring on the Situational Characteristic Questionnaire
Description
A measure of visual vertigo symptom level
Time Frame
Week 1 and Week 6
Secondary Outcome Measure Information:
Title
Change in scoring on the PHQ-9 Questionnaire from week one to six
Description
A measure of depression symptom level
Time Frame
Week 1 and Week 6
Title
Change in scoring on the GAD-7 Questionnaire from week one to six
Description
A measure of anxiety symptom level
Time Frame
Week 1 and Week 6
Other Pre-specified Outcome Measures:
Title
Subjective questionnaire
Description
A likert scale based questionnaire assessing acceptability of treatment
Time Frame
Week 6
Title
Change in head tracking observed at each weekly session for six weeks through numerical data extracted from the headset to show displacement of the head in the x, y and z planes of movement.
Description
Analysis of the head movement within each environment each week to see if there is any improvement
Time Frame
Week 1, 2, 3, 4, 5 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Those who have been diagnosed with visual vertigo and have scored a significant level on the Situational Characteristic Questionnaire (over 0.74 as per Pavlou et al., 2006). Exclusion Criteria: Those with or under investigation for epilepsy. Those who have been determined to have no or limited balance function in both ears. Those with reduced visual acuity that will leave them unable to view the 3D effects of the head mounted display. Those with severe mental health disorders e.g. psychosis, paranoid disorders, bipolar disorder or a history of substance abuse. Severe neck pain/ restricted movement. Previous treatment for visual vertigo. Those with an fluctuating vestibular disorder such as Ménière's disease or vestibular migraine. Those with untreated Benign Paroxymal Positional Vertigo (BPPV). Those with a significant brain injury, or head injury that results in a central vestibular disorder. Those with an arrhythmia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirsty M Walker, BSc
Phone
011427112131
Email
kirsty.walker@sth.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Bacon, PhD
Phone
01142712145
Email
paul.bacon@sth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsty M Walker, BSc
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsty M Walker, BSc
Phone
01142712131
Email
kirsty.walker@sth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Paul Bacon, PhD
Phone
01142712145
Email
paul.bacon@sth.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Use of Virtual Reality for the Treatment of Visual Vertigo.

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