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

NCT04071860 | Completed

• 1 other identifier: P02423
• Study Type: observational
• Target: 445
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnoea; Obstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  overnight (8-10 hours)

• Agreement in recorded body position between Safescan device and PSG

  overnight (8-10 hours)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged 18 years or older
• Able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Iceni Labs Ltd, Warwickshire, United Kingdom: collaborator

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ian Smith, MD

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: August 28, 2019
• Study Start: January 9, 2019
• Primary Completion: December 20, 2019
• Study Completion: July 31, 2021
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)