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

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.

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Device: NOX T3

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: observation; validation of observational arm	Device: NOX T3; portable sleep study device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.	compare the AHI of NOX T3 with reference to PSG	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2019.025

Drug and device information, study documents

• 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