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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnoea; Sleep Apnoea

• Study Type: Observational
• Enrollment (Actual): 445

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
      • Royal Papworth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the sleep laboratory for inpatient polysomnography, irrespective of working or known diagnosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
discovery and learning cohort; Data from this cohort will be used to develop the software algorithms
Validation; Data from this cohort will be used to validate the software algorithms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: Iceni Labs Ltd, Warwickshire, United Kingdom
• Investigators: Principal Investigator: Ian Smith, MD, Royal Papworth Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2019
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: P02423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No