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Sleep Apnoea Breathing Record Exploratory Study (SABRES) (SABRES)

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ClinicalTrials.gov Identifier: NCT06050720
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : April 10, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospitals of North Midlands NHS Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: Apne-Scan DC1 device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : March 26, 2024
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

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Arms and Interventions
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Arm Intervention/treatment
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.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Breathing pressure changes [ Time Frame: 2 months ]
    The primary outcome of interest is the data capture of the changing pressures in the user's breathing, whilst asleep, as recorded by the Apne-Scan DC1 device


Secondary Outcome Measures :
  1. Comparison between sleep apnoea devices [ Time Frame: 2 months ]
    An overall comparison of the sleep apnoea screening output from Apne-Scan DC1 with that from standard sleep apnoea test devices (ResMed NOX T3 and Phillips Alice Night One).

  2. 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.

  3. Severity of hypopnoea [ Time Frame: 2 months ]
    A comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050720


Locations
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United Kingdom
University Hospitals of North Midlands NHS Trust Recruiting
Stoke-on-Trent, United Kingdom
Contact: Megan Young    01782 675384    megan.young@uhnm.nhs.uk   
Principal Investigator: Ajit Thomas         
Sponsors and Collaborators
University Hospitals of North Midlands NHS Trust
More Information
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Responsible Party: University Hospitals of North Midlands NHS Trust
ClinicalTrials.gov Identifier: NCT06050720    
Other Study ID Numbers: 3282
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifiable data will be used in the results of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases