Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY) (STEADY)
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|ClinicalTrials.gov Identifier: NCT03726112|
Recruitment Status : Suspended (Under internal considerations)
First Posted : October 31, 2018
Last Update Posted : May 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Balance Disorders||Device: SpotOn Specs Device: Sham Specs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs for the Treatment of Chronic Dizziness & Imbalance|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||April 1, 2020|
Active Comparator: SpotOn Specs
Eyeglasses with Neuro-Balance Active (NBA) Spots
Device: SpotOn Specs
SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field
Sham Comparator: Sham Specs
Eyeglasses with spots placed in peripheral zones previously identified as neutral
Device: Sham Specs
- Change from Baseline in the Dizziness Handicap Inventory (DHI) [ Time Frame: baseline, 8 weeks ]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
- Clinical Global Impression of Improvement [ Time Frame: 8 weeks ]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"
- Change from baseline in the Clinical Global Impression of Severity [ Time Frame: baseline, 8 weeks ]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."
- Change from baseline in Postural sway [ Time Frame: baseline, 8 weeks ]Postural control will be measure during stance and gait
- Change from baseline in the Visual Vertigo Analog Scale (VVAS) [ Time Frame: baseline, 8 weeks ]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)
- Change from baseline in the Beck Anxiety Inventory [ Time Frame: baseline, 8 weeks ]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.
- Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF) [ Time Frame: baseline, 8 weeks ]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.
- Incident rate of falls [ Time Frame: 8 weeks ]Reported falls during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726112
|Assaf Harofeh Medical Center, Rishon LeZion, ENT Department|
|Rishon LeZion, Israel|
|Principal Investigator:||Nathan Shlamkovitz, MD||Assaf Harofeh Medical Center, Rishon LeZion, ENT Department|