An interventional study of Apne-Scan DC1 device in Sleep Apnea, sponsored by University Hospitals of North Midlands NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University Hospitals of North Midlands NHS Trust · Not applicable, Interventional, and Diagnostic
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's enrollment of 40 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Hospitals of North Midlands NHS Trust is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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.
Time frame: 2 months
Severity of Sleep Apnoea
A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices.
Time frame: 2 months
Severity of Hypopnoea
A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.
Time frame: 2 months
Comparison Between Sleep Apnoea Devices
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).
Time frame: 2 months
| Milestone | Sleep Disorder Patients |
|---|---|
| Started | 40 |
| Completed | 38 |
| Not completed | 2 |
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.
| correlation coefficient | Sleep Disorder Patients |
|---|---|
| Correlation Between the Trial Device and an Established Device | 0.955 |
A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices.
Results for this outcome have not been posted.
A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Collected over 6 months (duration of the study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sleep Disorder Patients | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Categorical(Participants) | Sleep Disorder Patients |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 33 |
| >=65 years | 5 |
| Age, Continuous(years) | Sleep Disorder Patients |
|---|---|
| Mean | 49 (23 to 69) |
| Sex: Female, Male(Participants) | Sleep Disorder Patients |
|---|---|
| Female | 17 |
| Male | 21 |
| Race/Ethnicity, Customized(Participants) | Sleep Disorder Patients |
|---|---|
| White British | 31 |
| Other white background | 1 |
| Other Asian background | 3 |
| Other | 3 |
| Region of Enrollment(Participants) | Sleep Disorder Patients |
|---|---|
| United Kingdom | 38 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No identifiable data will be used in the results of the study
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospitals of North Midlands NHS Trust