Obstructive Sleep Apnoea Clinical Trial
Official title:
Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study.
NCT number | NCT04071860 |
Other study ID # | P02423 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 9, 2019 |
Est. completion date | July 31, 2021 |
Verified date | September 2022 |
Source | Papworth Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.
Status | Completed |
Enrollment | 445 |
Est. completion date | July 31, 2021 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged 18 years or older - Able to give informed consent Exclusion Criteria: - Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study. - Polysomnography study records less than 4 hours of respiratory data |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Papworth Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Papworth Hospital NHS Foundation Trust | Iceni Labs Ltd, Warwickshire, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography | Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported. | overnight (8-10 hours) | |
Secondary | Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG | Agreement +/- 1 breath per minute between Safescan device and PSG | overnight (8-10 hours) | |
Secondary | Agreement in recorded body position between Safescan device and PSG | Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG | overnight (8-10 hours) |
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