Balance DisordersSTEADYNCT03726112
Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY)
A study testing SpotOn Specs in people with Balance Disorders, run by SpotOn Therapeutics Ltd. at 1 site in Israel.
Trial summary
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Balance Disorders
- What is being tested?
- SpotOn Specs
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 1 Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18≤ years ≤70
- DHI score of at least 36 (moderate to severe handicap)
- One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more
- Ability to perform all tests (including computerized test) and interviews
- At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable)
- Gave informed consent for participation in the study
Who cannot join
- Dizziness disease with fluctuating symptoms
- Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months
- Moderate-Severe Depression or Anxiety
- Known related eye disease
- Pregnant women
- Currently taken part in a clinical trial or within 30 days prior to screening
- Concomitant use of any medications that might affect the balance system
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
Rishon LeZiyyon
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 & Imbalance
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance.
- Conditions
- Balance Disorders
- Being tested
- SpotOn Specs, Sham Specs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpotOn SpecsDevice
SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field
Sham SpecsDevice
Sham device
| Study group | Role | What they receive |
|---|---|---|
| SpotOn Specs | Active comparator | Eyeglasses with Neuro-Balance Active (NBA) Spots Receives: Device: SpotOn Specs |
| Sham Specs | Sham comparator | Eyeglasses with spots placed in peripheral zones previously identified as neutral Receives: Device: Sham Specs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Dizziness Handicap Inventory (DHI)
The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale. A "yes" response to an item is awarded 4 points, a "sometimes" 2 points, and a "no", 0 points. Possible scores on the DHI range from 0 (suggesting no handicap) to 100, indicating significant perceived handicap
Measured: baseline, 8 weeks
Secondary outcomes (7)
Clinical Global Impression of Improvement
The Clinical Global Impression scale is a clinician-rated scale used to rate patients' improvement from baseline, based on the subject's baseline status- Improvement is rated on a scale of 1-7, with 1 being "very much improved" and 7 being "very much worse"
Measured: 8 weeks
Change from baseline in the Clinical Global Impression of Severity
A clinician-rated scale used to rate patients' severity of symptoms. Severity is rated on a scale of 1-7 with one being "normal, not at all ill," and 7 being "among the most extremely ill patients."
Measured: baseline, 8 weeks
Change from baseline in Postural sway
Postural control will be measure during stance and gait
Measured: baseline, 8 weeks
Change from baseline in the Visual Vertigo Analog Scale (VVAS)
A visual analogue scale subjects are asked to evaluate their subjective feeling of dizziness in the last week on a scale from 0 (no dizziness at all) to 10 (very severe dizziness)
Measured: baseline, 8 weeks
Change from baseline in the Beck Anxiety Inventory
A self-report inventory for measuring the severity of an individual's anxiety. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Measured: baseline, 8 weeks
Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF)
The VSS assesses symptoms of balance system dysfunction (for example, dizziness, vertigo, postural instability, and falling) and symptoms of somatic anxiety and autonomic arousal (diverse pains and somatic sensations, sweating, pounding heart, breathing difficulties, and fainting). A measure of symptom severity is obtained by summing the item scores. The total scale score ranges 0-60, higher scores indicating more severe problems.
Measured: baseline, 8 weeks
Incident rate of falls
Reported falls during the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Why it stopped: Under internal considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance DisordersStudies 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
- Model description
- A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpotOn Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nathan Shlamkovitz, MD, Principal investigator, Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726112
- Sponsor's protocol ID
- SpotOn_02
- Acronym
- STEADY
- Status last verified
- May 2019
- First submitted
- 15 Oct 2018
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. 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 & Imbalance
- ClinicalTrials.gov ID
- NCT03726112
- Acronym / sponsor ID
- STEADY / SpotOn_02
- Conditions
- Balance Disorders
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Under internal considerations
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- SpotOn Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 31 Oct 2018 (actual)
- 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.
A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase
| Arm | Type | Receives |
|---|---|---|
| SpotOn Specs | Active comparator | Device: SpotOn SpecsEyeglasses with Neuro-Balance Active (NBA) Spots |
| Sham Specs | Sham comparator | Device: Sham SpecsEyeglasses with spots placed in peripheral zones previously identified as neutral |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18≤ years ≤70
- DHI score of at least 36 (moderate to severe handicap)
- One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more
- Ability to perform all tests (including computerized test) and interviews
- At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable)
Key exclusion criteria (7 listed)
- Dizziness disease with fluctuating symptoms
- Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months
- Moderate-Severe Depression or Anxiety
- Known related eye disease
- 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 SpecsSpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field | Device | SpotOn Specs |
| Sham SpecsSham device | Device | Sham Specs |
Primary outcome
Change from Baseline in the Dizziness Handicap Inventory (DHI)
Time frame: baseline, 8 weeks
The Dizziness Handicap Inventory (DHI) is a 25-item self-assessment scale. A "yes" response to an item is awarded 4 points, a "sometimes" 2 points, and a "no", 0 points. Possible scores on the DHI range from 0 (suggesting no handicap) to 100, indicating significant perceived handicap
7 secondary outcomes
Clinical Global Impression of Improvement
Time frame: 8 weeks
Change from baseline in the Clinical Global Impression of Severity
Time frame: baseline, 8 weeks
Change from baseline in Postural sway
Time frame: baseline, 8 weeks
Change from baseline in the Visual Vertigo Analog Scale (VVAS)
Time frame: baseline, 8 weeks
Change from baseline in the Beck Anxiety Inventory
Time frame: baseline, 8 weeks
Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF)
Time frame: baseline, 8 weeks
Incident rate of falls
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
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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.
Nathan Shlamkovitz, MD principal investigator
Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
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 Specs in people with Balance Disorders, run by SpotOn Therapeutics Ltd. 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 6 inclusion and 7 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: paused, as of the sponsor's last update on 8 May 2019. 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?
Results are not available in the source record.
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?
Change from Baseline in the Dizziness Handicap Inventory (DHI) (time frame: baseline, 8 weeks). 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 8 May 2019.