Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial

NCT03661762 | Completed Results

• 1 other identifier: 240847 (28-02-18)
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical investigation of a medical device (CAVA) for recording eye movements. Healthy volunteers will wear the device for 23 hours a day, for 30 days. On 8 separate days of the trial they will induce optokinetic nystagmus (a normal reflex in response to full-field motion) by watching a short video of less than 1 minute in duration. The data will be analysed offline by a scientist, who will attempt to identify the dates that the nystagmus was induced.

Conditions

Optokinetic Nystagmus

Keywords

eye movements; electronystagmography; nystagmus; electrooculogram; vestibular assessment

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus

  Dates containing nystagmus. Of the \~450 days' worth of data captured during the study, 120 will contain artificially induced nystagmus. A computer algorithm has been developed at the University of East Anglia for detecting nystagmus. The key measurements are the sensitivity and specificity of the algorithm's results when applied to data captured during the trial. This measurement will be assessed post-trial.

  30 days

Secondary Outcomes (14)

• Post-trial Participant Questionnaire.

  30 days

• Compliance With the Device.

  30 days

• Data Usefulness

  30 days

• Data Usefulness

  30 days

• Event Marker Functioning

  30 days

Study Arms (1)

Healthy Volunteers

All trial participants are within this group. All trial participants will wear the CAVA device for up to 23 hours a day, for 30 days.

Device: CAVA

Interventions

CAVA DEVICE

prototype device for monitoring dizziness

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, aged 18 or over.

You may qualify if:

• Adults aged 18 and over
• 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 or damage around the forehead
• Potential participants who have an allergy to plasters and/or medical adhesives
• History of dizziness, vertigo, balance disorders, or syncope
• 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
• Unable to follow the testing protocol

Sponsors & Collaborators

• Julie Dawson: lead
• University of East Anglia: collaborator
• Medical Research Council: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

MeSH Terms

Conditions

Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Results Point of Contact

• Title: Mr John Phillips
• Organization: Norfolk and Norwich University Hospitals NHS Foundation Trust

john.phillips@mac.com

: +44 1603 593054

Study Officials

• John Phillips, Consultant

  Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Manager Research Services

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: September 7, 2018
• Study Start: August 23, 2018
• Primary Completion: December 12, 2018
• Study Completion: April 5, 2019
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Locations

GB (1)