Chronic DizzinessNCT01460121
Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
A study testing SpotOn's corrective elements for dizziness in people with Chronic Dizziness, run by Meir Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Dizziness
- What is being tested?
- SpotOn's corrective elements for dizziness
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
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
- Being tested
- SpotOn's corrective elements for dizziness, Placebo
- Keywords
- Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness, Motion and Space Discomfort, SpotOn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpotOn's corrective elements for dizzinessDevice
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.
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| SpotOn's corrective elements | Experimental | Not described Receives: Device: SpotOn's corrective elements for dizziness |
| Placebo corrective elements | Placebo comparator | Not described Receives: Device: SpotOn's corrective elements for dizziness; Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 4 weeks of treatment
Secondary outcomes (6)
Vertigo Symptom Scale-Short Form
Vertigo Symptom Scale-Short Form
Measured: After 4 weeks of treatment
Visual Vertigo Analog Scale (VVAS)
Visual Vertigo Analog Scale (VVAS)
Measured: After 4 weeks of treatment
The Activities-specific Balance Confidence (ABC) Scale
The Activities-specific Balance Confidence (ABC) Scale
Measured: After 4 weeks of treatment
Clinical Global Impressions-Improvement (CGI-I) scale
Clinical Global Impressions-Improvement (CGI-I) scale
Measured: After 4 weeks of treatment
Berg Balance Scale (BBS)
Berg Balance Scale (BBS)
Measured: After 4 weeks of treatment
Beck Anxiety Inventory (BAI)
Beck Anxiety Inventory (BAI)
Measured: After 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- SpotOn Therapeutics Ltd.
- Responsible party
- Principal investigator, carlos gordon, Meir Medical Center
- Investigators
- Carlos Gordon, Prof, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460121
- Sponsor's protocol ID
- SpotOn Specs 002
- Status last verified
- May 2018
- First submitted
- 25 Oct 2011
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs™ for the Treatment of Chronic Dizziness
- ClinicalTrials.gov ID
- NCT01460121
- Acronym / sponsor ID
- SpotOn Specs 002
- Conditions
- Chronic Dizziness
- Keywords
- Phobic Postural Vertigo, Visual Vertigo, Chronic Subjective Dizziness, Motion and Space Discomfort, SpotOn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- SpotOn Therapeutics Ltd.
- Study start
- Feb 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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!
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SpotOn's corrective elements | Experimental | Device: SpotOn's corrective elements for dizziness |
| Placebo corrective elements | Placebo comparator | Device: SpotOn's corrective elements for dizziness, Device: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpotOn's corrective elements for dizzinessEyeglasses 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 corrective elements, SpotOn's corrective elements |
| Placebo | Device | Placebo corrective elements |
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
6 secondary outcomes
Vertigo Symptom Scale-Short Form
Time frame: After 4 weeks of treatment
Visual Vertigo Analog Scale (VVAS)
Time frame: After 4 weeks of treatment
The Activities-specific Balance Confidence (ABC) Scale
Time frame: After 4 weeks of treatment
Clinical Global Impressions-Improvement (CGI-I) scale
Time frame: After 4 weeks of treatment
Berg Balance Scale (BBS)
Time frame: After 4 weeks of treatment
Beck Anxiety Inventory (BAI)
Time frame: After 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gordon, Prof principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpotOn's corrective elements for dizziness in people with Chronic Dizziness, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: After 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.