Clinical trial NCT03627169: PSG Validation of MATRx Plus AHI
Official title: PSG Validation of MATRx Plus AHI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Zephyr Sleep Technologies
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

OSA derives fundamentally from structural abnormalities of the pharynx that cause pharyngeal narrowing or closure during sleep and produce recurrent apneas and hypopneas. During wakefulness, compensatory neuromuscular reflexes protect the pharynx from collapse. These reflexes are lost during sleep, leaving the collapsible human pharynx susceptible to narrowing or closure. Owing largely to its association with excess body weight, OSA has arguably become the most prevalent chronic non-communicable disease in industrialized societies, assuming that obesity is not classified a disease. In addition to impairing quality of life, OSA conveys an increased risk of cardiovascular disease and vehicular accidents. The majority of apneics remain undiagnosed and untreated. Thus, OSA has the hallmarks of a major public health problem, affecting all age groups and increasing in epidemic proportions. Unfortunately, current medical practices seem ill-suited to dealing with the challenges posed by OSA.

Perhaps the most unsettling aspect of present medical practices relates to the cumbersome, uninviting, and expensive methods currently used to diagnose the disease. Common clinical experience indicates that individuals often resist undergoing the standard diagnostic test, an overnight in-hospital polysomnogram (PSG), because of the extensive attachments to the body surface. In other words, as public awareness of sleep apnea has increased so also has the negative impression of current testing. Any effective solution to the public health challenges posed by sleep apnea will have to consider the need for less cumbersome and off-putting clinical methods.

Zephyr Sleep Technologies has developed a device that has been approved for use in Canada. The device, MATRx plus, 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.

Once the participant arrives at the PSG laboratory, the clinical coordinator will obtain written informed consent, review inclusion and exclusion criteria, and enroll eligible participants into the study. The clinical coordinator will give the participant a brief overview on use of the MATRx plus Level III sleep recorder, then return to the control room to watch the participant set up the device via video. The participant will be made aware of the video recorded during set up the MATRx plus device. The device set up consists of: dual nares nasal cannula for airflow, respiratory effort belt, pulse oximeter, snoring (recorded via airflow frequency on the nasal cannula and via sound on the tablet), body position from an accelerometer built into the body-worn recorder. The sleep technician will then set the participant up with a standard PSG montage, consisting of: electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), pulse oximeter, nasal cannula, two respiratory effort belts, snoring, and body position (recorded via body-mounted accelerometer). Once the participant has both the MATRx plus and the PSG montage set up, the study will commence, and the participant will be monitored by video from the PSG control room, as is standard practice in a PSG. The sleep technician will intervene as necessary to ensure adequate signals are collected by the PSG equipment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Apnea and hypopnea events
timeFrame: 1 night
Secondary outcomes:
measure: Snoring events
timeFrame: 1 night
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Zephyr Sleep Technologies
state: Alberta
Study officials:
References:
citation: 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.