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Completed

NCT Number: NCT06050720

Sleep Apnoea Breathing Record Exploratory Study (SABRES)

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Apne-Scan DC1 device

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).

Primary outcomes

  1. Correlation Between the Trial Device and an Established Device

    Time frame: 2 months

    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.

Secondary outcomes

  1. Severity of Sleep Apnoea

    Time frame: 2 months

    A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices.

  2. Severity of Hypopnoea

    Time frame: 2 months

    A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.

Other outcomes

  1. Comparison Between Sleep Apnoea Devices

    Time frame: 2 months

    Comparing Apnea-Tech's UKCA Class I Apne-Scan DC1 sleep apnoea screening device in assisting a clinical diagnosis of obstructive sleep apnoea in comparison to standard sleep apnoea test devices (ResMed NOX T3 and Phillips Alice Night One).

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

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

Acronym: SABRES

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Jun 30, 2026

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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