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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
Sponsor:
Collaborator:
University of East Anglia
Information provided by (Responsible Party):
Norfolk and Norwich University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Sleep Device: CAVA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: CAVA
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
CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: John Phillips +44 1603 593054 john.phillips@mac.com
Contact: Jacob Newman +44 1603 593054 jacob.newman@uea.ac.uk

Locations
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United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust Recruiting
Norwich, Norfolk, United Kingdom, NR47UY
Contact: Julie Dawson    01603 647882 ext 7882    julie.dawson@nnuh.nhs.uk   
Contact: Ania Spurden    01603 289894 ext 5894    ania.spurdens@nnuh.nhs.uk   
Principal Investigator: John S Phillips         
Sub-Investigator: Alpar Lazar         
Sponsors and Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of East Anglia
Investigators
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Principal Investigator: John Phillips Norfolk and Norwich University Hospitals NHS Foundation Trust
Publications:
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Responsible Party: Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04583826    
Other Study ID Numbers: 272848 (209-11-19)
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norfolk and Norwich University Hospitals NHS Foundation Trust:
eye movements
electronystagmography
electrooculogram
sleep
polysomnography
REM sleep
Non-REM sleep