Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study

NHS Foundation Trust

Status: Completed

Conditions: Sleep Apnoea; Obstructive Sleep Apnoea

Study type: Observational

Funder types: Other

Identifiers

NCT04071860

P02423

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

445 participants in 2 patient groups

discovery and learning cohort

Description:

Data from this cohort will be used to develop the software algorithms

Validation

Description:

Data from this cohort will be used to validate the software algorithms