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Validation of a Portable Sleep Device in Patients With Co-existing Medical Illnesses

Using a Portable Monitoring Device for Diagnosing Obstructive Sleep Apnea in Patients With Multiple Co-existing Medical Illnesses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930316
Enrollment
80
Registered
2019-04-29
Start date
2019-04-01
Completion date
2021-12-31
Last updated
2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSA

Brief summary

The standard sleep study for diagnosing obstructive sleep apnea (OSA) in patients with co-existing illness is by conducting an attended polysomnography (PSG) with more than 7 channels for recording physiological parameters in the sleep center, as recommended by international guidelines. However the guidelines are more than 10 year old without update. With the growing and aging of the population, there is a need to explore if portable monitoring devices could be used in this group of population, so this group of patients can be managed in a timely manner. Portable monitoring devices have been used widely in patients without significant co-existing illness. These devices record at least 4 physiological parameters for diagnosing OSA and can be performed in an unattended setting e.g. at home because of the simplicity. This can shorten the waiting time for making a diagnosis using PSG. Eighty patients suspected of OSA, with stable co-existing illnesses, will be recruited for the study. Informed consent will be signed before participation. They will be offered a standard attended PSG in the sleep center. A portable monitoring device Nox T3 will be hooked up to the patients concurrently during the PSG.

Interventions

DEVICENOX T3

portable sleep study device

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients suspect of OSA (with or without symptoms) of age between 18 to 80 years old, with or without significant comorbidities. * Patients consent of concurrent use of both type I and or type III devices at the same time in hospital setting.

Exclusion criteria

* Pregnant patients. * Patients refuse to have both type I and type III devices used concurrently. * Patients with any co-existing medical illnesses which are unstable. Unstable is defined as: * Any recent hospital admission within 1 month before the schedule of sleep study * Any recent change of medication within 1 month before the schedule of sleep study * Any change in patient conditions requiring medical attention within 1 month before the schedule of sleep study.

Design outcomes

Primary

MeasureTime frameDescription
To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.1 yearcompare the AHI of NOX T3 with reference to PSG

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026