Trial Outcomes & Findings for Sleep Apnoea Breathing Record Exploratory Study (SABRES) (NCT NCT06050720)
NCT ID: NCT06050720
Last Updated: 2026-06-30
Results Overview
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.
COMPLETED
NA
40 participants
2 months
2026-06-30
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Apnoea Breathing Record Exploratory Study (SABRES)
Baseline characteristics by cohort
| Measure |
Sleep Disorder Patients
n=38 Participants
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).
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=20 Participants
|
|
Age, Continuous
|
49 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White British
|
31 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other white background
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other Asian background
|
3 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=20 Participants
|
|
Region of Enrollment
United Kingdom
|
38 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 2 monthsExploratory 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.
Outcome measures
| Measure |
Sleep Disorder Patients
n=38 Participants
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).
|
|---|---|
|
Correlation Between the Trial Device and an Established Device
|
0.955 correlation coefficient
|
SECONDARY outcome
Timeframe: 2 monthsA comparison stratified by the severity of the sleep apnoea indicated by standard sleep apnoea test devices.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 monthsA comparison stratified by the severity of the hypopnoea indicated by standard sleep apnoea test devices.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 monthsComparing 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).
Outcome measures
Outcome data not reported
Adverse Events
Sleep Disorder Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Aviva Ogbolosingha
University Hospitals of North Midlands NHS Trust
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place