Treatment of Visual Vertigo Clinical Trial
Official title:
The Use of Virtual Reality for the Treatment of Visual Vertigo.
| NCT number | NCT03020654 |
| Other study ID # | STH19451 |
| Secondary ID | 5375 |
| Status | Recruiting |
| Phase | N/A |
| First received | January 11, 2017 |
| Last updated | April 12, 2018 |
| Start date | January 2017 |
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.
| Status | Recruiting |
| Enrollment | 18 |
| Est. completion date | |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Hallamshire Hospital | Sheffield | South Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | University of Manchester |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Subjective questionnaire | A likert scale based questionnaire assessing acceptability of treatment | Week 6 | |
| Other | 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. | Analysis of the head movement within each environment each week to see if there is any improvement | Week 1, 2, 3, 4, 5 and 6 | |
| Primary | Change in scoring on the Situational Characteristic Questionnaire | A measure of visual vertigo symptom level | Week 1 and Week 6 | |
| Secondary | Change in scoring on the PHQ-9 Questionnaire from week one to six | A measure of depression symptom level | Week 1 and Week 6 | |
| Secondary | Change in scoring on the GAD-7 Questionnaire from week one to six | A measure of anxiety symptom level | Week 1 and Week 6 |