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

NCT ID: NCT01460121

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-10-31

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!

Conditions

Chronic Dizziness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SpotOn's corrective elements

Group Type: EXPERIMENTAL

SpotOn's corrective elements for dizziness

Intervention Type: DEVICE

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 corrective elements

Group Type: PLACEBO_COMPARATOR

SpotOn's corrective elements for dizziness

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Interventions

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.

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SpotOn Therapeutics Ltd.

INDUSTRY

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

carlos gordon

Professor, Department of Neurology, Meir Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Gordon, Prof

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Dept Neurology, Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

SpotOn Specs 002

Identifier Type: -

Identifier Source: org_study_id