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

March 2, 2021 updated by: Neurolign
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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical
  1. Oculo-Motility and Positional Testing,
  2. Caloric Testing
Other Names:
  • crHIT Vertical
Other: Control
120 aged matched controls
Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical
  1. Oculo-Motility and Positional Testing,
  2. Caloric Testing
Other Names:
  • crHIT Vertical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject discomfort - symptoms
Time Frame: 9 months
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.
9 months
Subject discomfort - test apparatus
Time Frame: 9 months
Subjects rate the comfort of chair, head rest and goggle on scale 1 to 5, where 1 is very uncomfortable and 5 very comfortable.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurolign

Collaborators

Mayo Clinic
University of Miami
University of Pittsburgh

Investigators

  • Principal Investigator: Michael E Hoffer, MD, University of Miami
  • Principal Investigator: Joseph Joseph Furman, PhD, University of Pittsburgh
  • Principal Investigator: Devin McCaslin,, PhD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • crHIT-vertical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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