Vestibular Function TestsNCT04087044
Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)
A study testing Computerized Rotational Head Impulse Test ( crHIT)-Vertical in people with Vestibular Function Tests, run by Neurolign at 3 sites in United States.
Trial summary
The purpose of this research study is to test whether a Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) is able to reliably evaluate the vertical semicircular canals in patients with vestibular dysfunctions. Read more about this study
- Who is it for?
- Ages 22 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Tests
- What is being tested?
- Computerized Rotational Head Impulse Test ( crHIT)-Vertical
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Sep 2019to 31 Aug 2022
- 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 22 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be willing to tolerate the placement of a set of goggles on their face
- Controls:
- no history of dizziness or imbalance
- normal responses on rotational chair testing
- Patients: persons clinically diagnosed with vestibular disorders
Who cannot join
- Pregnancy
- Neurodegenerative diseases
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami
Miami, Florida, 33136
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55902
About this study
The purpose of this research study is to test whether a Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) is able to reliably evaluate the vertical semicircular canals in patients with vestibular dysfunctions.
- Conditions
- Vestibular Function Tests
- Being tested
- Computerized Rotational Head Impulse Test ( crHIT)-Vertical
- Keywords
- vestibular neuritis, vestibular migraine
- Medical subject headings
- Vestibular Neuronitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Rotational Head Impulse Test ( crHIT)-VerticalDevice
Also called crHIT Vertical
- Oculo-Motility and Positional Testing,
- Caloric Testing
| Study group | Role | What they receive |
|---|---|---|
| Vestibular dysfunction | Experimental | 66 patients: 30 patients with surgically confirmed unilateral loss, 15 patients with absent ice water calorics and resulting from vestibular neuritis and 21 patients with vestibular migraine Receives: Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical |
| Control | Other | 120 aged matched controls Receives: Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of crHIT-vertical
How many participants are correctly identified as either having a vestibular dysfunction or being healthy controls
Measured: 9 months
Secondary outcomes (2)
Subject discomfort - symptoms
Number of subjects indicating motion sickness symptoms during the crHIT test. If motion sickness is present subjects are asked to rate the symptoms of motion sickness and severity on scale 1 to 5, where 1 is minimum and 5 is severe.
Measured: 9 months
Subject discomfort - test apparatus
Subjects rate the comfort of chair, head rest and goggle on scale 1 to 5, where 1 is very uncomfortable and 5 very comfortable.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start6 Sep 2019
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular Function TestsStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 66 patients (30 patients with surgically confirmed unilateral loss, 15 patients with absent ice water calorics and resulting from vestibular neuritis and 21 patients with vestibular migraine) 120 controls
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurolign
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami, University of Pittsburgh, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Michael E Hoffer, MD, Principal investigator, University of MiamiJoseph Joseph Furman, PhD, Principal investigator, University of PittsburghDevin McCaslin,, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087044
- Sponsor's protocol ID
- crHIT-vertical
- Status last verified
- Mar 2021
- First submitted
- 10 Sep 2019
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)
- ClinicalTrials.gov ID
- NCT04087044
- Acronym / sponsor ID
- crHIT-vertical
- Conditions
- Vestibular Function Tests
- Keywords
- vestibular neuritis, vestibular migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- NeurolignIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami, University of Pittsburgh, Mayo Clinic
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 12 Sep 2019 (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 purpose of this research study is to test whether a Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) is able to reliably evaluate the vertical semicircular canals in patients with vestibular dysfunctions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 66 patients (30 patients with surgically confirmed unilateral loss, 15 patients with absent ice water calorics and resulting from vestibular neuritis and 21 patients with vestibular migraine) 120 controls
| Arm | Type | Receives |
|---|---|---|
| Vestibular dysfunction | Experimental | Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical66 patients: 30 patients with surgically confirmed unilateral loss, 15 patients with absent ice water calorics and resulting from vestibular neuritis and 21 patients with vestibular migraine |
| Control | Other | Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical120 aged matched controls |
Who may qualify
- Ages
- 22 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be willing to tolerate the placement of a set of goggles on their face
- Controls:
- Patients: persons clinically diagnosed with vestibular disorders
Key exclusion criteria (2 listed)
- Pregnancy
- Neurodegenerative diseases
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 |
|---|---|---|
| Computerized Rotational Head Impulse Test ( crHIT)-VerticalAlso: crHIT Vertical1. Oculo-Motility and Positional Testing, 2. Caloric Testing | Device | Control, Vestibular dysfunction |
Primary outcome
Sensitivity and specificity of crHIT-vertical
Time frame: 9 months
How many participants are correctly identified as either having a vestibular dysfunction or being healthy controls
2 secondary outcomes
Subject discomfort - symptoms
Time frame: 9 months
Subject discomfort - test apparatus
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
Michael E Hoffer, MD principal investigator
University of Miami
Joseph Joseph Furman, PhD principal investigator
University of Pittsburgh
Devin McCaslin,, PhD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Rotational Head Impulse Test ( crHIT)-Vertical in people with Vestibular Function Tests, run by Neurolign at 3 sites in United States.
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 2 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
Sensitivity and specificity of crHIT-vertical (time frame: 9 months). 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 3 Mar 2021.