NCT04142697

Brief Summary

The purpose this study is to measure sensitivity to visual and vestibular or balance motion. It is hoped that the results may help researchers better understand how aging and disease affect motion perception.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Sep 2020Sep 2027

First Submitted

Initial submission to the registry

October 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

October 21, 2019

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Heading perception

    Heading perception will be measured using two alternative forced choice and magnitude estimation procedures and reported in degrees. It is measured in degrees of azimuth with positive to the right and negative to the left of straight ahead (defined as 0 degrees).

    Baseline to 1 week

Secondary Outcomes (1)

  • Change in Mean Dizziness Handicap Inventory (DHI)

    Baseline to 1 week

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR
Behavioral: Heading direction adaptation

Vestibular Disease patients

ACTIVE COMPARATOR
Behavioral: Heading direction adaptation

Interventions

Will adapt subject's perceived heading direction using exposure to visual environments that include rotation and situations where visual and inertial heading direction are systematically offset.

Healthy subjectsVestibular Disease patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects:
  • general good health
  • Vestibular Disease patients:
  • general good health
  • specific unilateral or bilateral vestibular loss

You may not qualify if:

  • Healthy subjects:
  • subjects who are institutionalized or otherwise not self-sufficient.
  • enduring sequelae due to diseases of the nervous system, eyes, ears, head and neck, and limbs, except for changes commensurate with normal aging (e.g. presbyacusic hearing loss, mild cataract, etc.).
  • abnormal cognitive function, which if in question can be determined as a score of \<27 on the Mini-Mental State test.
  • corrected visual acuity worse than 20/20 up to age 65, worse than 20/40 if \>65
  • abnormal binocular stereo-acuity or visual fields.
  • any defects in cranial nerve, oculomotor, cerebellar/coordination, and somatosensory functions.
  • any abnormal oculomotor and vestibular function (caloric tests)
  • Vestibular Disease patients:
  • Inability to perform the study tasks due to sensory, motor, or postural limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14618, United States

RECRUITING

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 29, 2019

Study Start

September 15, 2020

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data provided upon request to principal investigator

Locations