Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY)

Study Overview
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Brief Summary
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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 & Imbalance.

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 & Imbalance

Conditions
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Balance Disorders

Intervention / Treatment
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* Device: SpotOn Specs
* Device: Sham Specs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18≤ years ≤70 DHI score of at least 36 (moderate to severe handicap) One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more Ability to perform all tests (including computerized test) and interviews At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable) Gave informed consent for participation in the study Exclusion Criteria: Dizziness disease with fluctuating symptoms Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months Moderate-Severe Depression or Anxiety Known related eye disease Pregnant women Currently taken part in a clinical trial or within 30 days prior to screening Concomitant use of any medications that might affect the balance system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SpotOn Specs<br>Eyeglasses with Neuro-Balance Active (NBA) Spots | Device: SpotOn Specs<br>* SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field<br>|
| Sham Comparator: Sham Specs<br>Eyeglasses with spots placed in peripheral zones previously identified as neutral | Device: Sham Specs<br>* Sham device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Dizziness Handicap Inventory (DHI) | The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale. A yes response to an item is awarded 4 points, a sometimes 2 points, and a no, 0 points. Possible scores on the DHI range from 0 (suggesting no handicap) to 100, indicating significant perceived handicap | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of Improvement | The Clinical Global Impression scale is a clinician-rated scale used to rate patients' improvement from baseline, based on the subject's baseline status- Improvement is rated on a scale of 1-7, with 1 being very much improved and 7 being very much worse | 8 weeks | 
| Change from baseline in the Clinical Global Impression of Severity | A clinician-rated scale used to rate patients' severity of symptoms. Severity is rated on a scale of 1-7 with one being normal, not at all ill, and 7 being among the most extremely ill patients. | baseline, 8 weeks | 
| Change from baseline in Postural sway | Postural control will be measure during stance and gait | baseline, 8 weeks | 
| Change from baseline in the Visual Vertigo Analog Scale (VVAS) | A visual analogue scale subjects are asked to evaluate their subjective feeling of dizziness in the last week on a scale from 0 (no dizziness at all) to 10 (very severe dizziness) | baseline, 8 weeks | 
| Change from baseline in the Beck Anxiety Inventory | A self-report inventory for measuring the severity of an individual's anxiety. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. | baseline, 8 weeks | 
| Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF) | The VSS assesses symptoms of balance system dysfunction (for example, dizziness, vertigo, postural instability, and falling) and symptoms of somatic anxiety and autonomic arousal (diverse pains and somatic sensations, sweating, pounding heart, breathing difficulties, and fainting). A measure of symptom severity is obtained by summing the item scores. The total scale score ranges 0-60, higher scores indicating more severe problems. | baseline, 8 weeks | 
| Incident rate of falls | Reported falls during the study | 8 weeks |