Treatment of Visual VertigoNCT03020654
The Use of Virtual Reality for the Treatment of Visual Vertigo.
A study testing Virtual environment with fast moving objects and Virtual environment with no movement in people with Treatment of Visual Vertigo, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Visual Vertigo
- What is being tested?
- Virtual environment with fast moving objects and Virtual environment with no movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
Kirsty M Walker, BSc, 01142712131, kirsty.walker@sth.nhs.uk
Paul Bacon, PhD, 01142712145, paul.bacon@sth.nhs.uk
About this study
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.
Read the 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.
- Conditions
- Treatment of Visual Vertigo
- Being tested
- Virtual environment with fast moving objects, Virtual environment with no movement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual environment with fast moving objectsOther
A beach/park environment with graded moving objects, the individual will complete head and eye exercises.
Virtual environment with no movementOther
A beach/park environment with static objects, the individual will complete head and eye exercises.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 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. Receives: Other: Virtual environment with fast moving objects |
| Control group | Active comparator | 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. Receives: Other: Virtual environment with no movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scoring on the Situational Characteristic Questionnaire
A measure of visual vertigo symptom level
Measured: Week 1 and Week 6
Secondary outcomes (2)
Change in scoring on the PHQ-9 Questionnaire from week one to six
A measure of depression symptom level
Measured: Week 1 and Week 6
Change in scoring on the GAD-7 Questionnaire from week one to six
A measure of anxiety symptom level
Measured: Week 1 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Visual VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Kirsty M Walker, BSc, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020654
- Sponsor's protocol ID
- STH19451
- Other IDs
- 5375
- Status last verified
- Oct 2017
- First submitted
- 11 Jan 2017
- Last updated
- 13 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality for the Treatment of Visual Vertigo.
- ClinicalTrials.gov ID
- NCT03020654
- Acronym / sponsor ID
- STH19451
- Conditions
- Treatment of Visual Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- Jan 2017
- Primary completion
- Nov 2018 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Virtual environment with fast moving objectsVirtual 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. |
| Control group | Active comparator | Other: Virtual environment with no movementVirtual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual environment with fast moving objectsA beach/park environment with graded moving objects, the individual will complete head and eye exercises. | Other | Treatment group |
| Virtual environment with no movementA beach/park environment with static objects, the individual will complete head and eye exercises. | Other | Control group |
Primary outcome
Change in scoring on the Situational Characteristic Questionnaire
Time frame: Week 1 and Week 6
A measure of visual vertigo symptom level
2 secondary outcomes
Change in scoring on the PHQ-9 Questionnaire from week one to six
Time frame: Week 1 and Week 6
Change in scoring on the GAD-7 Questionnaire from week one to six
Time frame: Week 1 and Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty M Walker, BSc principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual environment with fast moving objects and Virtual environment with no movement in people with Treatment of Visual Vertigo, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsty M Walker, BSc (011427112131, kirsty.walker@sth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scoring on the Situational Characteristic Questionnaire (time frame: Week 1 and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.