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

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01460121

Collaborator

SpotOn Therapeutics Ltd. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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!

Condition or Disease	Intervention/Treatment	Phase
Chronic Dizziness	Device: SpotOn's corrective elements for dizziness Device: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SpotOn's corrective elements	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.
Placebo Comparator: Placebo corrective elements	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

Arm

Intervention/Treatment

Experimental: SpotOn's corrective elements

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.

Placebo Comparator: Placebo corrective elements

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

Outcome Measures

Primary Outcome Measures

Dizziness Handicap Inventory (DHI) [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

Secondary Outcome Measures

Vertigo Symptom Scale-Short Form [After 4 weeks of treatment]
Vertigo Symptom Scale-Short Form
Visual Vertigo Analog Scale (VVAS) [After 4 weeks of treatment]
Visual Vertigo Analog Scale (VVAS)
The Activities-specific Balance Confidence (ABC) Scale [After 4 weeks of treatment]
The Activities-specific Balance Confidence (ABC) Scale
Clinical Global Impressions-Improvement (CGI-I) scale [After 4 weeks of treatment]
Clinical Global Impressions-Improvement (CGI-I) scale
Berg Balance Scale (BBS) [After 4 weeks of treatment]
Berg Balance Scale (BBS)
Beck Anxiety Inventory (BAI) [After 4 weeks of treatment]
Beck Anxiety Inventory (BAI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.