Sleep Apnea
Conditions
Brief 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.
Interventions
DEVICEApne-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).
Sponsors
University Hospitals of North Midlands NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants will have been referred to the sleep clinic at Royal Stoke Hospital for a diagnosis of a possible sleep disorder, possibly sleep apnoea. If they enrol in the study the participants will be asked to wear the Apne-Scan DC1 device to changing pressures in the user's breathing whilst asleep.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between the Trial Device and an Established Device | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of Sleep Apnoea | 2 months | A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices. |
| Severity of Hypopnoea | 2 months | A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices. |
Countries
United Kingdom
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Age, Continuous | 49 years |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized Other Asian background | 3 Participants |
| Race/Ethnicity, Customized Other white background | 1 Participants |
| Race/Ethnicity, Customized White British | 31 Participants |
| Region of Enrollment United Kingdom | 38 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
None listed