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

Vestibular Function Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04087044
• Other study ID #: crHIT-vertical
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2021
• Source: Neurolign
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Function Tests

Intervention

Device:
• Computerized Rotational Head Impulse Test ( crHIT)-Vertical
Oculo-Motility and Positional Testing, Caloric Testing

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Neurolign	Mayo Clinic, University of Miami, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of crHIT-vertical	How many participants are correctly identified as either having a vestibular dysfunction or being healthy controls	9 months
Secondary	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.	9 months
Secondary	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.	9 months