VertigoNCT04447066
The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients
An observational study of Vertigo and Dizziness, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study. Read more about this study
- Who is it for?
- Ages 65 years and older
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 31 Jul 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients hospitalized at the rehabilitation department
Who may be able to join
- Over 65 years old
- Hospitalized at the rehabilitation department
Who cannot join
- Blindness or loss of vision which is not corrected using glasses
- Past CVA with neurological remnants
- Movement disorder
- Lower body part weakness
- Limitation in neck movement
- Vestibular pathology diagnosed in the past 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Semicircular Canals Dysfunction Among Patients Hospitalized at the Rehabilitation Department
Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study.
- Being tested
- No intervention
- Medical subject headings
- Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention - VHIT will be used but without intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized at the rehabilitation department | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Video Head Impulse Test (vHIT) results
The results of the vHIT study in terms of gain and saccades
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447066
- Sponsor's protocol ID
- 255-20
- Status last verified
- Jun 2020
- First submitted
- 23 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semicircular Canals Dysfunction Among Patients Hospitalized at the Rehabilitation Department
- ClinicalTrials.gov ID
- NCT04447066
- Acronym / sponsor ID
- 255-20
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 25 Jun 2020 (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.
Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized at the rehabilitation department | – | Other: No intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients hospitalized at the rehabilitation department
Key inclusion criteria (2 listed)
- Over 65 years old
- Hospitalized at the rehabilitation department
Key exclusion criteria (6 listed)
- Blindness or loss of vision which is not corrected using glasses
- Past CVA with neurological remnants
- Movement disorder
- Lower body part weakness
- Limitation in neck movement
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 |
|---|---|---|
| No interventionNo intervention - VHIT will be used but without intervention | Other | Patients hospitalized at the rehabilitation department |
Primary outcome
Video Head Impulse Test (vHIT) results
Time frame: 1 year
The results of the vHIT study in terms of gain and saccades
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and Dizziness, run by Tel-Aviv Sourasky Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Yahav Oron, MD (+972-6973573, oron.yahav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Video Head Impulse Test (vHIT) results (time frame: 1 year). 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 25 Jun 2020.