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N/A N=40 Diagnostic

Sleep Apnoea Breathing Record Exploratory Study (SABRES)

Sleep Apnea

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Correlation Between the Trial Device and an Established Device — 0.955 correlation coefficient

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Apne-Scan DC1 device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University Hospitals of North Midlands NHS Trust
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Correlation Between the Trial Device and an Established Device
0.955
SECONDARY
Severity of Sleep Apnoea
SECONDARY
Severity of Hypopnoea

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06050720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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