Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep disorder patients | Other | The study participants have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of North Midlands NHS Trust | Stoke-on-Trent | United Kingdom |
No identifiable data will be used in the results of the study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | correlation coefficient | 2 months |
|
6 months (duration of the study)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aviva Ogbolosingha | University Hospitals of North Midlands NHS Trust | 01782 675380 | aviva.ogbolosingha@uhnm.nhs.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2023 | Dec 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 2 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Severity of Sleep Apnoea | A comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices. | Not Posted | 2 months | Participants |
| Secondary | Severity of Hypopnoea | A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices. | Not Posted | 2 months | Participants |
| Other Pre-specified | 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). | Not Posted | 2 months | Participants |
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
Not provided
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |