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OpenTrials
Completed

NCT Number: NCT03930316

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

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.

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Key information

Conditions

OSA

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NOX T3

Device

portable sleep study device

Primary outcomes

  1. To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.

    Time frame: 1 year

    compare the AHI of NOX T3 with reference to PSG

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2019
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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