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

NCT03726112 | Suspended

• 1 other identifier: SpotOn_02
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Balance Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Clinical Global Impression of Improvement

  8 weeks

• Change from baseline in the Clinical Global Impression of Severity

  baseline, 8 weeks

• Change from baseline in Postural sway

  baseline, 8 weeks

• Change from baseline in the Visual Vertigo Analog Scale (VVAS)

  baseline, 8 weeks

• Change from baseline in the Beck Anxiety Inventory

  baseline, 8 weeks

Study Arms (2)

SpotOn Specs

ACTIVE COMPARATOR

Eyeglasses with Neuro-Balance Active (NBA) Spots

Device: SpotOn Specs

Sham Specs

SHAM COMPARATOR

Eyeglasses with spots placed in peripheral zones previously identified as neutral

Device: Sham Specs

Interventions

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

SpotOn Specs

Sham Specs DEVICE

Sham device

Sham Specs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SpotOn Therapeutics Ltd.: lead

Study Sites (1)

Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

Rishon LeZiyyon, Israel

Location

Study Officials

• Nathan Shlamkovitz, MD

  Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 31, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: April 1, 2020
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

IL (1)