Clinical trial NCT03020654: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment of Visual Vertigo
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2017-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in scoring on the Situational Characteristic Questionnaire
timeFrame: Week 1 and Week 6
Secondary outcomes:
measure: Change in scoring on the PHQ-9 Questionnaire from week one to six
timeFrame: Week 1 and Week 6
measure: Change in scoring on the GAD-7 Questionnaire from week one to six
timeFrame: Week 1 and Week 6
Other outcomes:
measure: Subjective questionnaire
timeFrame: Week 6
measure: 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.
timeFrame: Week 1, 2, 3, 4, 5 and 6
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Kirsty M Walker, BSc
role: PRINCIPAL_INVESTIGATOR
References: