Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

NCT ID: NCT04087044

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vestibular Function Tests

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Vestibular dysfunction

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

Group Type EXPERIMENTAL

Computerized Rotational Head Impulse Test ( crHIT)-Vertical

Intervention Type DEVICE

1. Oculo-Motility and Positional Testing,
2. Caloric Testing

Control

120 aged matched controls

Group Type OTHER

Computerized Rotational Head Impulse Test ( crHIT)-Vertical

Intervention Type DEVICE

1. Oculo-Motility and Positional Testing,
2. Caloric Testing

Interventions

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Computerized Rotational Head Impulse Test ( crHIT)-Vertical

1. Oculo-Motility and Positional Testing,
2. Caloric Testing

Intervention Type DEVICE

Other Intervention Names

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crHIT Vertical

Eligibility Criteria

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Inclusion Criteria

* Subjects must be willing to tolerate the placement of a set of goggles on their face
* Controls:

1. no history of dizziness or imbalance
2. normal responses on rotational chair testing
* Patients: persons clinically diagnosed with vestibular disorders

Exclusion Criteria

* Pregnancy
* Neurodegenerative diseases
Minimum Eligible Age

22 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Neurolign

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael E Hoffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Joseph Joseph Furman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Devin McCaslin,, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of Miami

Miami, Florida, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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crHIT-vertical

Identifier Type: -

Identifier Source: org_study_id

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