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

Not Applicable

• Conditions: Vestibular Function Tests
• Interventions: Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical

• Registration Number: NCT04087044
• Lead Sponsor: Neurolign

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular dysfunction	Computerized Rotational Head Impulse Test ( crHIT)-Vertical	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
Control	Computerized Rotational Head Impulse Test ( crHIT)-Vertical	120 aged matched controls

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of crHIT-vertical	9 months	How many participants are correctly identified as either having a vestibular dysfunction or being healthy controls

Secondary Outcome Measures

Name	Time	Method
Subject discomfort - symptoms	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.
Subject discomfort - test apparatus	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.

Trial Locations

Locations (3)

University of Miami; 🇺🇸 Miami, Florida, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States