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

Chronic Dizziness research study

What is the primary objective of this study?

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!

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Dizziness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:SpotOn's corrective elements for dizzinessEyeglasses 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

SpotOn's corrective elements

Placebo corrective elements

Study Status

Unknown status

Start Date: February 2012

Completed Date: October 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Dizziness Handicap Inventory (DHI)

Secondary Outcome: Vertigo Symptom Scale-Short Form

Study sponsors, principal investigator, and references

Principal Investigator: Carlos Gordon, Prof

Lead Sponsor: Meir Medical Center

Collaborator: SpotOn Therapeutics LTD

More information:https://clinicaltrials.gov/show/NCT01460121

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