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

SpotOn Therapeutics

Status: Suspended

Conditions: Balance Disorders

Treatments: Device: SpotOn Specs; Device: Sham Specs

Study type: Interventional

Funder types: Industry

Identifiers

NCT03726112

SpotOn_02

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

SpotOn Specs

Active Comparator group

Description:

Eyeglasses with Neuro-Balance Active (NBA) Spots

Treatment:

Device: SpotOn Specs

Sham Specs

Sham Comparator group

Description:

Eyeglasses with spots placed in peripheral zones previously identified as neutral

Treatment:

Device: Sham Specs