NCT04087044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

2.7 years

First QC Date

September 10, 2019

Last Update Submit

March 2, 2021

Conditions

Vestibular Function Tests

Keywords

vestibular neuritisvestibular migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Subject discomfort - symptoms

    9 months

  • Subject discomfort - test apparatus

    9 months

Study Arms (2)

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

Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical

Control

OTHER

120 aged matched controls

Device: Computerized Rotational Head Impulse Test ( crHIT)-Vertical

Interventions

Computerized Rotational Head Impulse Test ( crHIT)-VerticalDEVICE

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

Also known as: crHIT Vertical
ControlVestibular dysfunction

Eligibility Criteria

Age22 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Neurodegenerative diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55902, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vestibular Neuronitis

Condition Hierarchy (Ancestors)

Vestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Michael E Hoffer, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Joseph Joseph Furman, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Devin McCaslin,, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

September 12, 2019

Study Start

September 6, 2019

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)