Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

Study Overview
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Brief Summary
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The diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. However, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. Patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. These cases have been described in the medical literature as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable. Because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso Mental Balance Technology) developed to alleviate the feelings of dizziness. Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!

Official Title
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A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

Conditions
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Chronic Dizziness

Intervention / Treatment
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* Device: SpotOn's corrective elements for dizziness
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18≤ years ≤85 Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder. Stable symptoms for more than one month and less than a year. Ability to perform all tests (including computerized test) and interviews. Gave informed consent for participation in the study. Exclusion Criteria: Dizziness disease with fluctuating symptoms such as in active Meniere's disease or Benign Paroxysmal Positional Vertigo CNS disease or injuries Dizziness caused as a result of previous whiplash Any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.) Pregnant women Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpotOn's corrective elements<br> | Device: SpotOn's corrective elements for dizziness<br>* Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.<br>|
| Placebo Comparator: Placebo corrective elements<br> | Device: SpotOn's corrective elements for dizziness<br>* Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.<br>Device: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) | The change from baseline in dizziness symptoms as measured by Dizziness Handicap Inventory (DHI) The change from baseline in balance as measured by the Activities-specific and Balance Confidence (ABC) Scale. Safety:AE incidence Physical, neuro-otologic and neurological examination Static/dynamic/positioning examination | After 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo Symptom Scale-Short Form | Vertigo Symptom Scale-Short Form | After 4 weeks of treatment | 
| Visual Vertigo Analog Scale (VVAS) | Visual Vertigo Analog Scale (VVAS) | After 4 weeks of treatment | 
| The Activities-specific Balance Confidence (ABC) Scale | The Activities-specific Balance Confidence (ABC) Scale | After 4 weeks of treatment | 
| Clinical Global Impressions-Improvement (CGI-I) scale | Clinical Global Impressions-Improvement (CGI-I) scale | After 4 weeks of treatment | 
| Berg Balance Scale (BBS) | Berg Balance Scale (BBS) | After 4 weeks of treatment | 
| Beck Anxiety Inventory (BAI) | Beck Anxiety Inventory (BAI) | After 4 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness, Motion and Space Discomfort, SpotOn