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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03930316
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 30, 2020
Information provided by (Responsible Party):
To Kin Wang, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
OSA Device: NOX T3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Validation Study of a Portable Monitoring Device for Diagnosing OSA in Patients With Co-existing Medical Illnesses
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Device: NOX T3
    portable sleep study device

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03930316

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Contact: KW To 85235052211

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Hong Kong
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK Recruiting
Shatin, Hong Kong
Contact: KW To, MBChB    852 26322211      
Principal Investigator: KW To, MBChB         
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: To Kin Wang, Associate consultant, Chinese University of Hong Kong Identifier: NCT03930316    
Other Study ID Numbers: 2019.025
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No