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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
Sponsor:
Information provided by (Responsible Party):
SpotOn Therapeutics Ltd.

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.

Condition or disease Intervention/treatment Phase
Balance Disorders Device: SpotOn Specs Device: Sham Specs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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"

  2. 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."

  3. Change from baseline in Postural sway [ Time Frame: baseline, 8 weeks ]
    Postural control will be measure during stance and gait

  4. 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)

  5. 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.

  6. 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.

  7. Incident rate of falls [ Time Frame: 8 weeks ]
    Reported falls during the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Israel
Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
Rishon LeZion, Israel
Sponsors and Collaborators
SpotOn Therapeutics Ltd.
Investigators
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Principal Investigator: Nathan Shlamkovitz, MD Assaf Harofeh Medical Center, Rishon LeZion, ENT Department

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Responsible Party: SpotOn Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT03726112     History of Changes
Other Study ID Numbers: SpotOn_02
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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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