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Currently, you can access the following clinical trials being conducted worldwide:

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219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03930316

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted June 30, 2020

Study Description

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:OSA
  • Intervention/Treatment: Device: NOX T3
  • Phase: N/A
Detailed Description


Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 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.

Contacts and Locations

Contact: KW To 85235052211 tokw617@yahoo.com.hk


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

Sponsors and Collaborators

Chinese University of Hong Kong

More Information
  • Responsible Party: Chinese University of Hong Kong
  • ClinicalTrials.gov Identifier: NCT03930316 History of Changes
  • Other Study ID Numbers: 2019.025
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: June 30, 2020
  • Last Verified: June 2020
  • 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.: Yes