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

Balance Disorders Clinical Trial

— STEADY  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03726112
• Other study ID #: SpotOn_02
• Status: Suspended
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2019
• Source: SpotOn Therapeutics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 110
• Est. completion date: April 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Balance Disorders

Intervention

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 Specs
Sham device

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center, Rishon LeZion, ENT Department	Rishon LeZion

Sponsors (1)

Lead Sponsor	Collaborator
SpotOn Therapeutics Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change from baseline in Postural sway	Postural control will be measure during stance and gait	baseline, 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Incident rate of falls	Reported falls during the study	8 weeks