Clinical Trials Directory

Trials / Completed

CompletedNCT03930316

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
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENOX T3portable sleep study device

Timeline

Start date
2019-04-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2019-04-29
Last updated
2023-08-31

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT03930316. Inclusion in this directory is not an endorsement.