NCT05889676

Brief Summary

A Validation study in which the standard separate cVEMP and oVEMP will be compared with a new protocol in which the cVEMP and oVEMP can be recorded simultaneously in response to a mastoid vibration by bone transducer B250

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

May 16, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

May 16, 2023

Last Update Submit

July 14, 2025

Conditions

Vertigo

Outcome Measures

Primary Outcomes (1)

  • response rate

    during the procedure

Interventions

VEMP by bone conductionDIAGNOSTIC_TEST

New bone conducted VEMP elicited by transducer B250

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all adult patients attedning the balance laboratory at Karolinska University Hospital after written consent.

You may qualify if:

  • ) dizzy patients attending the balance laboratory -

You may not qualify if:

  • ) age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Hearing and Balance Unit

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 5, 2023

Study Start

May 30, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)