Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01460121
Recruitment Status : Active, not recruiting
First Posted : October 26, 2011
Last Update Posted : April 6, 2016
SpotOn Therapeutics LTD
Information provided by (Responsible Party):
carlos gordon, Meir Medical Center

October 25, 2011
October 26, 2011
April 6, 2016
February 2012
October 2015   (Final data collection date for primary outcome measure)
Dizziness Handicap Inventory (DHI) [ Time Frame: After 4 weeks of treatment ]

The change from baseline in dizziness symptoms as measured by Dizziness Handicap Inventory (DHI)

The change from baseline in balance as measured by the Activities-specific and Balance Confidence (ABC) Scale.

Safety:AE incidence Physical, neuro-otologic and neurological examination Static/dynamic/positioning examination

Same as current
Complete list of historical versions of study NCT01460121 on Archive Site
Vertigo Symptom Scale-Short Form [ Time Frame: After 4 weeks of treatment ]
Vertigo Symptom Scale-Short Form Dynamic Gait Index 10 Meter Walk test. Berg Balance Scale (BBS) SF-36 Beck Depression Inventory Index Beck Anxiety Inventory index
Same as current
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Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

The diagnosis and management of acute vertigo and dizziness is most of the time an easy task for the general practitioner. However, following an acute vestibular disorder and very often with no any overt cause, a considerable number of patients complain on chronic dizziness and subjective disturbance of balance despite normal clinical and laboratory tests. Patients describe that perceptual visual stimulus provoke or aggravate their symptoms that are frequently accompanied by anxiety. These cases have been described in the medical literature as Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness and Motion and Space Discomfort (2,3,4,5). Treatment of these conditions includes physical therapy (similar to vestibular rehabilitation exercises) and anti-anxiety or anti-depressant agents such as benzodiazepines and SSRI, however, the effectiveness of these approaches is debatable.

Because visual stimuli play a crucial role in space orientation and motion perception, it is reasonable to hypothesize that certain visual stabilizing signals applied on the peripheral visual field (that is involved mainly in the perception of motion) could be of help in patients suffering from dizziness. This is the rationale of a new technology (SMB- Senso Mental Balance Technology) developed to alleviate the feelings of dizziness.

Trial is conducted in Meir Medical Center, Israel. Recruitment only in Israel!

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Dizziness
  • Device: SpotOn's corrective elements for dizziness
    Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.
  • Device: Placebo
  • Experimental: SpotOn's corrective elements
    Intervention: Device: SpotOn's corrective elements for dizziness
  • Placebo Comparator: Placebo corrective elements
    • Device: SpotOn's corrective elements for dizziness
    • Device: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
October 2016
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18≤ years ≤85
  • Clinical diagnosis of chronic dizziness primary or secondary to vestibular disorder.
  • Stable symptoms for more than one month and less than a year.
  • Ability to perform all tests (including computerized test) and interviews.
  • Gave informed consent for participation in the study.

Exclusion Criteria:

  • Dizziness disease with fluctuating symptoms such as in active Meniere's disease or Benign Paroxysmal Positional Vertigo
  • CNS disease or injuries
  • Dizziness caused as a result of previous whiplash
  • Any active or non-controlled disease that might cause dizziness (e.g. non-controlled diabetes, hypertension, anemia, respiratory, cardiovascular or endocrinological disorder etc.)
  • Pregnant women
  • Participation currently in another clinical study or enrolled in another clinical study within 30 days prior to this study.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
SpotOn Specs 002
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carlos gordon, Meir Medical Center
Meir Medical Center
SpotOn Therapeutics LTD
Principal Investigator: Carlos Gordon, Prof Meir Medical Center
Meir Medical Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP