Clinical Trial: Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
Brief Summary:
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!
Detailed Summary:
Sponsor: Meir Medical Center
Current Primary Outcome: 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
Original Primary Outcome: Same as current
Current Secondary Outcome: Vertigo Symptom Scale-Short Form [ Time Frame: After 4 weeks of treatment ]
Original Secondary Outcome: Same as current
Information By: Meir Medical Center
Dates:
Date Received: October 25, 2011
Date Started: February 2012
Date Completion: October 2016
Last Updated: April 5, 2016
Last Verified: April 2016
