Sleep Apnoea Breathing Record Exploratory Study (SABRES) (SABRES)

An Exploratory Study of a Novel, Low-cost Sleep Apnoea Screening Device to Compare Its Capability to Identify Apnoeas and Hypopneas With Current Standard Sleep Apnoea Test Devices

During sleep, many people have times when they breathe shallowly or completely stop. If a person stops breathing for more than 10 seconds, this is called an 'apnoea'. If shallow breathing lasts for more than 10 seconds, it is called a 'hypopnoea'. If a person has these events frequently, it disrupts their sleep and they do not awake refreshed. It can also put strain on the heart, leading to cardiovascular conditions. These sleep disorders, usually called 'Sleep Apnoea', can be treated for most people using 'continuous positive airways pressure', CPAP. Current tests for sleep apnoea, usually used at home, are expensive, complicated for patients to use and do not monitor actual breathing. The new test, called Apne-Scan, is very simple and will cost less than the standard tests. It just requires the user to wear a mask, similar to ones used for CPAP treatment, overnight and then send the mask off for data analysis. The Apne-Scan mask, developed with taxpayer funding, is fitted with a pressure sensor to monitor actual breathing. People between the ages of 18-70 who have been referred to the sleep clinic at Royal Stoke University Hospital are eligible to participate in this exploratory study. They will wear the Apne-Scan mask at the same time as their standard overnight sleep apnoea test. The breathing data collected by Apne-Scan will be analysed by Apnea-Tech Limited, the device manufacturers, so that it can be compared to the data captured by the standard sleep apnoea test.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Apne-Scan DC1 device

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Stoke-on-Trent, United Kingdom
    • University Hospitals of North Midlands NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea.
• Be about to be screened for possible sleep apnoea using a standard sleep apnoea test device.
• Be between the ages of 18 and 75 and have provided informed consent for the study

Exclusion Criteria:

• Have not been referred by a clinician to a sleep clinic for diagnostic tests for sleep disorders other than for possible sleep apnoea.
• Cannot tolerate wearing a mask overnight.
• Cannot remove a mask should they become distressed.
• Are not capable of understanding the English language version of Apne-Scan's Instructions For Use (IFU).
• Are under the age of 18 years old or over the age of 75 years old.
• Are not capable of giving informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sleep disorder patients; The study participants have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea.	Device: Apne-Scan DC1 device; The primary objective of this exploratory study is to assess Apnea-Tech's UKCA Class I Apne-Scan DC1 sleep apnoea screening device in assisting a clinical diagnosis of sleep apnoea in comparison to standard sleep apnoea test devices (ResMed NOX T3 and Phillips Alice Night One).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between the Trial Device and an Established Device	Exploratory study to look for correlation between the Apnoea Hyopopnea index (AHI) as measured by the Trial device (ApneScan) to the AHI measured by NOX T3 device (Standard Sleep home diagnostic kit). Both devices were worn concurrently overnight at home to allow for a data comparison.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Sleep Apnoea	A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices.	2 months
Severity of Hypopnoea	A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.	2 months

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: 3282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No identifiable data will be used in the results of the study

Drug and device information, study documents

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