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

Chronic Dizziness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460121
• Other study ID #: SpotOn Specs 002
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2018
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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!

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Dizziness
• Dizziness
• Vertigo

Intervention

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

Locations

Country	Name	City	State
Israel	Dept Neurology, Meir Medical Center	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	SpotOn Therapeutics LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dizziness Handicap Inventory (DHI)	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	After 4 weeks of treatment
Secondary	Vertigo Symptom Scale-Short Form	Vertigo Symptom Scale-Short Form	After 4 weeks of treatment
Secondary	Visual Vertigo Analog Scale (VVAS)	Visual Vertigo Analog Scale (VVAS)	After 4 weeks of treatment
Secondary	The Activities-specific Balance Confidence (ABC) Scale	The Activities-specific Balance Confidence (ABC) Scale	After 4 weeks of treatment
Secondary	Clinical Global Impressions-Improvement (CGI-I) scale	Clinical Global Impressions-Improvement (CGI-I) scale	After 4 weeks of treatment
Secondary	Berg Balance Scale (BBS)	Berg Balance Scale (BBS)	After 4 weeks of treatment
Secondary	Beck Anxiety Inventory (BAI)	Beck Anxiety Inventory (BAI)	After 4 weeks of treatment