Sudden Sensorineural Hearing LossNCT04224909
Video HIT in Sudden Sensorineural Hearing Loss
An observational study of Sudden Sensorineural Hearing Loss, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Sensorineural Hearing Loss
- What is being tested?
- Video Head Impulse Test
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Sudden Sensorineural Hearing Loss
Who may be able to join
- Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss
Who cannot join
- Vertigo
- Other etiology causing dizziness
- Neurological dysfunction othe than the hearing loss
- Difficulty performing the vHIT
- Chronic vestibular disorder
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Video HIT Results in Sudden Sensorineural Hearing Loss Patients
The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test
- Conditions
- Sudden Sensorineural Hearing Loss
- Being tested
- Video Head Impulse Test
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Head Impulse TestDiagnostic test
Diagnosis of dysfunction of the semicircular canals using the vHIT
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sudden Sensorineural Hearing Loss | Not described Receives: Diagnostic Test: Video Head Impulse Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gain of each canal, as calculated using the vHIT
Gain measured by the vHIT system
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT04224909
- Sponsor's protocol ID
- 0633-19-TLV
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video HIT Results in Sudden Sensorineural Hearing Loss Patients
- ClinicalTrials.gov ID
- NCT04224909
- Acronym / sponsor ID
- 0633-19-TLV
- Conditions
- Sudden Sensorineural Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 13 Jan 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.
The function of the vestibular system among patients with Sudden Sensori Neural Hearing Loss will be evaluted using the video Head Impulse Test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Sudden Sensorineural Hearing Loss | – | Diagnostic Test: Video Head Impulse Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Sudden Sensorineural Hearing Loss
Key inclusion criteria (1 listed)
- Patients hospitalized with the diagnosis of Sudden Sensorineural Hearing Loss
Key exclusion criteria (6 listed)
- Vertigo
- Other etiology causing dizziness
- Neurological dysfunction othe than the hearing loss
- Difficulty performing the vHIT
- Chronic vestibular disorder
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 |
|---|---|---|
| Video Head Impulse TestDiagnosis of dysfunction of the semicircular canals using the vHIT | Diagnostic test | Patients with Sudden Sensorineural Hearing Loss |
Primary outcome
The gain of each canal, as calculated using the vHIT
Time frame: 15 minutes
Gain measured by the vHIT system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 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 Sudden Sensorineural Hearing Loss, 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 1 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 13 Jan 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 (036973573, yahavo@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gain of each canal, as calculated using the vHIT (time frame: 15 minutes). 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 13 Jan 2020.