NCT04583826

Brief Summary

Clinical investigation of a medical device (CAVA) for recording eye movements. Forty volunteers will sleep in a specially designed sleep lab for one or two nights, depending on whether they are enrolled onto phase 1 (two nights) or phase 2 (one night) of the study. Each volunteer will wear the CAVA device along with a Polysomnography (PSG) device, which is the gold standard for monitoring sleep. The twenty participants in phase 2 will simultaneously wear a commercially available consumer device for monitoring sleep. The eye movement data captured using CAVA will be processed by novel computer algorithms to classify the sleep stages in the data into Rapid Eye Movement (REM), non-REM and awake. The results will be compared with the ground-truth from the gold standard, and also compared to the results from the commercially available device. The aim of the study is to determine whether CAVA could be a viable and competitive home-monitoring device for analysing sleep.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

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

April 2, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

5 years

First QC Date

September 23, 2020

Last Update Submit

December 15, 2023

Conditions

Sleep

Keywords

eye movementselectronystagmographyelectrooculogramsleeppolysomnographyREM sleepNon-REM sleep

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of the results

    The sensitivity and specificity of the results obtained by a bespoke computer algorithm for detecting stages of sleep, as captured by the CAVA device.

    Study duration, approximately 6 months

Secondary Outcomes (1)

  • Sensitivity and specificity of the results

    Study duration, approximately 6 months

Study Arms (1)

CAVA

EXPERIMENTAL

20 participants will wear the CAVA device, and a consumer-grade sleep monitoring device, and undergo polysomnography, for one night. 40 participants will wear the CAVA device and undergo polysomnography for two nights

Device: CAVA

Interventions

CAVADEVICE

CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.

CAVA

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Conversational English and capacity to consent
  • Availability to take part in the study

You may not qualify if:

  • Potential participants who have a diagnosed sleep disorder, ongoing neurological or psychiatric disorders, or any potentially life-threatening conditions.
  • 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).
  • Pregnant or nursing mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

Location

Related Publications (2)

  • Liu Y, Wheaton AG, Chapman DP, Cunningham TJ, Lu H, Croft JB. Prevalence of Healthy Sleep Duration among Adults--United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Feb 19;65(6):137-41. doi: 10.15585/mmwr.mm6506a1.

    PMID: 26890214BACKGROUND

  • Hafner M, Stepanek M, Taylor J, Troxel WM, van Stolk C. Why Sleep Matters-The Economic Costs of Insufficient Sleep: A Cross-Country Comparative Analysis. Rand Health Q. 2017 Jan 1;6(4):11. eCollection 2017 Jan.

    PMID: 28983434BACKGROUND

Study Officials

  • John Phillips

    Norfolk and Norwich University Hospitals NHS Foundation Trust

    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

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 12, 2020

Study Start

April 2, 2020

Primary Completion

April 1, 2025

Study Completion

May 31, 2025

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations

GB(1)