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A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea. With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster. The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed. Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care. If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Queen Alexandra Hospital
Portsmouth, United Kingdom
Start Date
February 28, 2017
Primary Completion Date
May 2, 2017
Completion Date
May 2, 2017
Last Updated
August 29, 2018
127
ACTUAL participants
RespiraSense Sleep Screener
DEVICE
Lead Sponsor
PMD Solutions
Collaborators
NCT05451875
NCT04506684
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04649775