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NCT Number: NCT04071860

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography

    Time frame: 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 outcomes

  1. Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG

    Time frame: overnight (8-10 hours)

    Agreement +/- 1 breath per minute between Safescan device and PSG

  2. Agreement in recorded body position between Safescan device and PSG

    Time frame: overnight (8-10 hours)

    Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Iceni Labs Ltd, Warwickshire, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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