PSG Validation of MATRx Plus AHI

NCT03627169 | Completed FDA Device

• 1 other identifier: ZCP201704
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea and hypopnea events

  The number of apnea and hypopnea events collected from each the MATRx plus device and PSG will be recorded in order to determine the sensitivity/specificity of the MATRx plus device.

  1 night

Secondary Outcomes (1)

• Snoring events

  1 night

Study Arms (1)

MATRx plus/PSG group

Healthy individuals, individuals suspected of having OSA, and individuals with a previous diagnosis of OSA will spend a single night in a sleep laboratory and undergo a standard polysomnogram simultaneously with a Level III sleep study using the MATRx plus device. There is no interventional aspect to the study.

Device: MATRx plus

Interventions

MATRx plus DEVICE

The MATRx plus device will be used in its capacity as a Level III home sleep apnea test (HSAT). Note: MATRx plus is approved for use in Canada; therefore, the study does not involve any investigational devices.

MATRx plus/PSG group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals, individuals who suspect they may have OSA, and individuals who have previously been diagnosed with or treated for OSA will be recruited for the trial. Only participants who meet all eligibility criteria will be enrolled.

You may qualify if:

• Aged between 21 and 80 years
• Ability to understand and provide informed consent
• Ability and willingness to meet the required schedule

You may not qualify if:

• Inability to breathe comfortably through the nose
• Symptomatic, non-respiratory sleep disorder, e.g., restless leg syndrome, chronic insomnia
• Heart failure
• Cerebral vascular incident within the last 12 months
• Use of pacemaker or other life-supporting device

Sponsors & Collaborators

• Zephyr Sleep Technologies: lead

Study Sites (1)

Zephyr Sleep Technologies

Calgary, Alberta, T2H2C3, Canada

Location

Related Publications (1)

• Topor ZL, Remmers JE, Grosse J, Mosca EV, Jahromi SAZ, Zhu Y, Bruehlmann S. Validation of a new unattended sleep apnea monitor using two methods for the identification of hypopneas. J Clin Sleep Med. 2020 May 15;16(5):695-703. doi: 10.5664/jcsm.8324. Epub 2020 Feb 6.

  PMID: 32024586 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 13, 2018
• Study Start: July 25, 2017
• Primary Completion: February 1, 2018
• Study Completion: July 3, 2019
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)