N/A
Completed N=18
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Healthy Volunteer Trial
Optokinetic Nystagmus
Source: ClinicalTrials.gov NCT03661762 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus — 99.1; 98.6 Percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of a Computer Algorithm to Detect Artificially Induced Nystagmus |
99.1; 98.6 | — |
| SECONDARY Post-trial Participant Questionnaire. |
— | — |
| SECONDARY Compliance With the Device. |
82; 100 | — |
| SECONDARY Data Usefulness |
— | — |
| SECONDARY Event Marker Functioning |
100 | — |
| SECONDARY Time Stamp Accuracy |
-17.49 | — |
| SECONDARY Accelerometer Functioning |
97; 100; 100; 93; 100; 97 | — |
| SECONDARY Accuracy of Nystagmus Beat Direction |
— | — |
| SECONDARY Accuracy of Nystagmus Onset Time |
— | — |
| SECONDARY Accuracy of Nystagmus Finishing Time |
— | — |
| SECONDARY Accuracy of Nystagmus Peak Time |
— | — |
| SECONDARY Accuracy of Nystagmus Frequency |
— | — |
| SECONDARY Data Drop-outs |
4 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03661762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.