NCT03627169

PSG Validation of MATRx Plus AHI

Completed Last updated 4 March 2021

What this trial tests

trial testing MATRx plus in Obstructive Sleep Apnea in 34 participants. Completed in 3 July 2019.

Timeline

25 July 2017

Primary endpoint
1 February 2018

3 July 2019

Quick facts

Lead sponsor	Zephyr Sleep Technologies
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	25 July 2017
Primary completion	1 February 2018
Estimated completion	3 July 2019
Sites	1 location across Canada

Drugs / interventions tested

• MATRx plus

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Zephyr Sleep Technologies

Who can join

Adults 21 to 80, any sex, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs. Almost thirty years ago, initial population studies found the prevalence of OSA to be five to nine percent of the adult population. Excess body weight is a risk factor for the development of OSA, and the recent rise in prevalence of obesity has led to revised estimates of OSA prevalence, now at seventeen per cent of the adult population. OSA is poorly recognized clinically; 85% of apneics remain undiagnosed and untreated.

Currently, the diagnosis of OSA commonly relies on an overnight, in-hospital polysomnogram (PSG). Due to the extensive attachments to the body surface required in a PSG, it has developed a negative impression. Any effective solution to the public health challenges posed by sleep apnea will have to consider the need for less cumbersome and off-putting methods.

Zephyr Sleep Technologies has developed a device that has been approved for use in Canada. The MATRx plus device functions as both a Level III sleep recorder (records respiratory airflow, respiratory effort, pulse rate, and arterial oxygen saturation) as well as a home-based system to select patients for oral appliance therapy. The American Academy of Sleep Medicine (AASM) recommends the use of apnea-hypopnea index (AHI) for the diagnosis and categorization of OSA severity. The Level III function of the MATRx plus device is approved for use in Canada with two autoscoring methods: oxygen desaturation index, ODI and apnea-hypopnea index, AHI, but requires further validation of AHI for clearance by the US Food and Drug Administration (FDA).

The proposed research will validate the AHI autoscoring function of the MATRs plus Level III home sleep recorder by comparing it to data recorded in a PSG, which is considered to be the gold standard for sleep testing. Though the effectiveness of the AHI autoscoring algorithm has been previously established, it has not been validated against PSG data. Additionally, other parameters such as snoring will be examined in order to develop scoring algorithms for other facets of sleep disordered breathing.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Validation of a new unattended sleep apnea monitor using two methods for the identification of hypopneas.
   Topor ZL, Remmers JE, Grosse J, Mosca EV, et al · · 2020 · cited 7× · PMID 32024586 · DOI 10.5664/jcsm.8324