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Under internal considerations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpotOn Specs | Active Comparator | Eyeglasses with Neuro-Balance Active (NBA) Spots |
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| Sham Specs | Sham Comparator | Eyeglasses with spots placed in peripheral zones previously identified as neutral |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpotOn Specs | Device | SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Shlamkovitz, MD | Assaf Harofeh Medical Center, Rishon LeZion, ENT Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center, Rishon LeZion, ENT Department | Rishon LeZiyyon | Israel |
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A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase
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| Sham Specs | Device | Sham device |
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| 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 |