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

Completed

• Conditions: Obstructive Sleep Apnoea; Sleep Apnoea

• Registration Number: NCT04071860
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Primary Completion: 2019-12-20
• Study Completion: 2021-07-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Papworth Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom