sCAVA - Sleep Assessment Using the CAVA Device (sCAVA)
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|ClinicalTrials.gov Identifier: NCT04583826|
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sleep||Device: CAVA||Not Applicable|
The Centres for Disease Control and Prevention (CDC) in the US has declared insufficient sleep a 'public health problem' . 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) .
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||sCAVA - Sleep Assessment Using the CAVA Device|
|Actual Study Start Date :||April 2, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||May 31, 2021|
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
CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.
- 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.
- Sensitivity and specificity of the results [ Time Frame: Study duration, approximately 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583826
|Contact: John Phillips||+44 1603 email@example.com|
|Contact: Jacob Newman||+44 1603 firstname.lastname@example.org|
|Norfolk and Norwich University Hospitals NHS Foundation Trust||Recruiting|
|Norwich, Norfolk, United Kingdom, NR47UY|
|Contact: Julie Dawson 01603 647882 ext 7882 email@example.com|
|Contact: Ania Spurden 01603 289894 ext 5894 firstname.lastname@example.org|
|Principal Investigator: John S Phillips|
|Sub-Investigator: Alpar Lazar|
|Principal Investigator:||John Phillips||Norfolk and Norwich University Hospitals NHS Foundation Trust|