SleepsCAVANCT04583826
sCAVA - Sleep Assessment Using the CAVA Device
A study testing CAVA in people with Sleep, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- CAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Apr 2020to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Conversational English and capacity to consent
- Availability to take part in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR47UY
About this study
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.
Read the detailed description
The Centres for Disease Control and Prevention (CDC) in the US has declared insufficient sleep a 'public health problem' [1]. Over 35% of adults in the United Kingdom (UK) sleep less than 7 hours and 16% sleep less than 6 hours per night and the proportion of people getting less than the recommended hours of sleep is rising (Liu et al., 2014). This is alarming as insufficient sleep can lead to increased mortality, accidents, and mistakes at work and is also linked with many chronic conditions-such as obesity, type 2 diabetes, heart disease, depression and neurodegeneration -that threaten the wellbeing of an increasing number of people across the globe. On an annual basis, the UK loses an estimated 207,000 working days due to insufficient sleep (mainly related to absenteeism) and the estimated economic cost of insufficient sleep in the UK is over 50 billion dollars, that is 1.86 % of the national Gross Domestic Product (GDP) [2].
Early detection of sleep problems is imperative for prevention of this process, however it is hindered by current technology, where the gold standard is represented by a laborious and expensive method called polysomnography (PSG). Therefore, the need for innovative technologies allowing the reliable monitoring of sleep behaviour in the home-environment using non-invasive, user friendly and broadly accessible methods is immense. This study aims to assess the suitability of the CAVA device (Continuous Ambulatory Vestibular Assessment) that was originally developed by Norfolk and Norwich University Hospitals (NNUH) clinicians and University of East Anglia (UEA scientists to monitor dizziness, for the purpose of diagnosing sleep conditions. The CAVA device is designed to record head and eye-movements continuously over several weeks. Such signals are known to be useful for sleep state diagnosis, and the preliminary analyses show that the data collected by the CAVA device clearly delineate sleep and wake episodes so it is therefore plausible that the CAVA device can be used for home-based sleep monitoring. The investigators term this new application sCAVA. The objective of the proposed study is to re-purpose the CAVA device as a reliable and broadly accessible sleep monitoring tool by developing, testing and validating algorithms to interpret sCAVA data for sleep monitoring purposes.
- Conditions
- Sleep
- Being tested
- CAVA
- Keywords
- eye movements, electronystagmography, electrooculogram, sleep, polysomnography, REM sleep, Non-REM sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVADevice
CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: CAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study duration, approximately 6 months
Secondary outcomes (1)
Sensitivity and specificity of the results
The sensitivity and specificity of the results obtained by a commercially available device for detecting stages of sleep will be compared to the results obtained by CAVA.
Measured: Study duration, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start2 Apr 2020
- Primary completion5 Nov 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- John Phillips, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583826
- Sponsor's protocol ID
- 272848 (209-11-19)
- Acronym
- sCAVA
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2020
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26890214Hafner 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.
PubMed 28983434
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sCAVA - Sleep Assessment Using the CAVA Device
- ClinicalTrials.gov ID
- NCT04583826
- Acronym / sponsor ID
- sCAVA / 272848 (209-11-19)
- Conditions
- Sleep
- Keywords
- eye movements, electronystagmography, electrooculogram, sleep, polysomnography, REM sleep, Non-REM sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Centres for Disease Control and Prevention (CDC) in the US has declared insufficient sleep a 'public health problem' [1]. Over 35% of adults in the United Kingdom (UK) sleep less than 7 hours and 16% sleep less than 6 hours per night and the proportion of people getting less than the recommended hours of sleep is rising (Liu et al., 2014). This is alarming as insufficient sleep can lead to increased mortality, accidents, and mistakes at work and is also linked with many chronic conditions-such as obesity, type 2 diabetes, heart disease, depression and neurodegeneration -that threaten the wellbeing of an increasing number of people across the globe. On an annual basis, the UK loses an estimated 207,000 working days due to insufficient sleep (mainly related to absenteeism) and the estimated economic cost of insufficient sleep in the UK is over 50 billion dollars, that is 1.86 % of the national Gross Domestic Product (GDP) [2].
Early detection of sleep problems is imperative for prevention of this process, however it is hindered by current technology, where the gold standard is represented by a laborious and expensive method called polysomnography (PSG). Therefore, the need for innovative technologies allowing the reliable monitoring of sleep behaviour in the home-environment using non-invasive, user friendly and broadly accessible methods is immense. This study aims to assess the suitability of the CAVA device (Continuous Ambulatory Vestibular Assessment) that was originally developed by Norfolk and Norwich University Hospitals (NNUH) clinicians and University of East Anglia (UEA scientists to monitor dizziness, for the purpose of diagnosing sleep conditions. The CAVA device is designed to record head and eye-movements continuously over several weeks. Such signals are known to be useful for sleep state diagnosis, and the preliminary analyses show that the data collected by the CAVA device clearly delineate sleep and wake episodes so it is therefore plausible that the CAVA device can be used for home-based sleep monitoring. The investigators term this new application sCAVA. The objective of the proposed study is to re-purpose the CAVA device as a reliable and broadly accessible sleep monitoring tool by developing, testing and validating algorithms to interpret sCAVA data for sleep monitoring purposes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVA | Experimental | Device: CAVA20 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age
- Conversational English and capacity to consent
- Availability to take part in the study
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVACAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes. | Device | CAVA |
Primary outcome
Sensitivity and specificity of the results
Time frame: Study duration, approximately 6 months
The sensitivity and specificity of the results obtained by a bespoke computer algorithm for detecting stages of sleep, as captured by the CAVA device.
1 secondary outcome
Sensitivity and specificity of the results
Time frame: Study duration, approximately 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 26890214Liu 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.
- Background: PubMed 28983434Hafner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Phillips principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAVA in people with Sleep, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the results (time frame: Study duration, approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04583826, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.