CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled / 40 target
Drug / intervention
Apne-Scan DC1 devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06050720
NCT06050720N/ACompletedOn Track (1.5/mo)Completion was 22mo ago

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

University Hospitals of North Midlands NHS Trust·interventional·Posted Sep 22, 2023·Updated Jun 30, 2026

In Brief

A clinical study evaluating Apne-Scan DC1 device for Sleep Apnea. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedSep 22, 2023
Enrollment StartMar 26, 2024
Primary CompletionAug 31, 2024
Study CompletionNov 4, 2025
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 2.8 years ago

Arms & Interventions

Sleep disorder patientsother

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

Interventions

Apne-Scan DC1 devicedevice

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).