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

Obstructive Sleep Apnoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071860
• Other study ID #: P02423
• Status: Completed
• Start date: January 9, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2022
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Apnoea

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Iceni Labs Ltd, Warwickshire, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

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)