Overview

This trial is active, not recruiting.

Condition chronic dizziness
Treatments spoton's corrective elements for dizziness, placebo
Sponsor Meir Medical Center
Collaborator SpotOn Therapeutics LTD
Start date February 2012
End date October 2015
Trial size 40 participants
Trial identifier NCT01460121, SpotOn Specs 002

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!

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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)
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

Primary Outcomes

Measure
Dizziness Handicap Inventory (DHI)
time frame: After 4 weeks of treatment

Secondary Outcomes

Measure
Vertigo Symptom Scale-Short Form
time frame: After 4 weeks of treatment

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
Principal investigator Carlos Gordon, Prof
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Meir Medical Center.