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

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

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

Study Overview

• Status: Suspended
• Conditions: Balance Disorders
• Intervention / Treatment: Device: SpotOn Specs; Device: Sham Specs

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Rishon LeZion, Israel
    • Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Sham device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SpotOn Therapeutics Ltd.
• Investigators: Principal Investigator: Nathan Shlamkovitz, MD, Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SpotOn_02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No