Obstructive Sleep Apnoea, Sleep Apnoea
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Iceni Labs Ltd, Warwickshire, United Kingdom
Papworth Hospital NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography | overnight (8-10 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG | overnight (8-10 hours) | Agreement +/- 1 breath per minute between Safescan device and PSG |
| Agreement in recorded body position between Safescan device and PSG | overnight (8-10 hours) | Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG |
Countries
United Kingdom
Outcome results
None listed