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

SpotOn Therapeutics Ltd.110 enrolled

Overview

A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

110

Conditions

Balance Disorders

Interventions

SpotOn SpecsDEVICE

SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field

Sham SpecsDEVICE

Sham device

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

Rishon LeZiyyon, Israel

Outcomes

Primary Outcomes

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

Time frame: baseline, 8 weeks

Secondary Outcomes

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"

Time frame: 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."

Time frame: baseline, 8 weeks

Change from baseline in Postural sway

Postural control will be measure during stance and gait

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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