NCT04026516

Brief Summary

Clinical investigation of a medical device (CAVA) for recording eye movements. Patients suffering from diagnosed dizziness conditions will wear the device for 23 hours a day, for 30 days. The device will capture normal eye movement data as well as data corresponding to any dizzy events experienced. At the end of the trial, the data will be downloaded and a scientist will perform a blinded analysis of the data. Specifically, they will attempt to identify the dates on which dizziness was reported.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

July 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

5.9 years

First QC Date

July 8, 2019

Last Update Submit

December 18, 2023

Conditions

Meniere's DiseaseBenign Paroxysmal Positional VertigoRecurrent VestibulopathyVestibular Migraine

Keywords

eye movementsElectronystagmograpynystagmuselectrooculogramvestibular assessmentambulatory monitoring

Outcome Measures

Primary Outcomes (1)

  • Nystagmus detection sensitivity and specificity of 95%

    The investigators will determine the sensitivity and specificity of the results obtained by a bespoke computer algorithm for detecting episodes of nystagmus, from data captured by the CAVA device.

    30 days

Secondary Outcomes (5)

  • Post-trial participant questionnaire

    30 days

  • Compliance with wearing the device

    30 days

  • Functionality of the device's accelerometer

    30 days

  • Functionality of the device's event marker

    30 days

  • Functionality of the device's timestamping capabilities

    30 days

Study Arms (1)

CAVA Dizziness Trial Arm

EXPERIMENTAL

All trial participants are within this arm. All participants will wear the CAVA device for 30 days and follow the same procedures throughout the trial.

Device: CAVA Device

Interventions

CAVA DeviceDEVICE

The CAVA device will be worn continuously for thirty days, during which time it will record eye and head movements

CAVA Dizziness Trial Arm

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 and over.
  • Patients experiencing episodes of true vertigo, with at least two episodes within the preceding month. Relevant medical conditions include Meniere's disease, Benign Paroxysmal Positional Vertigo (BPPV), recurrent vestibulopathy and vestibular migraine.
  • Able to commit to 30 days of continuous wear of the trial device as per the study plan.
  • Own a telephone.

You may not qualify if:

  • Potential participants who have a history of dermatological disease, fragile skin, or damage around the forehead.
  • Potential participants who have an allergy to plasters and/or medical adhesives - (similarly to materials used in the device).
  • History of hypertension or cardiac problems (uncontrolled, acute or de-compensated - phase).
  • History of ear disease, or previous ear surgery.
  • History of psychotic/neurotic disorders or epilepsy.
  • History of eye disease, or previous eye surgery.
  • Pregnant or nursing mothers.
  • Potential participants who have taken part in a previous CAVA trial.
  • Potential participants who are currently taking part in another trial.
  • Unable to follow the testing protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Meniere DiseaseBenign Paroxysmal Positional VertigoVestibular NeuronitisNystagmus, Pathologic

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesVertigoVestibular DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesCranial Nerve DiseasesOcular Motility DisordersEye Diseases

Study Officials

  • John Phillips, Consultant

    Dr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Services Manager

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 19, 2019

Study Start

July 1, 2019

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

December 22, 2023

Record last verified: 2023-12

Locations

GB(1)