PSG Validation of MATRx Plus AHI
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Observational

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.
    

Intervention name(s): MATRx plus
Intervention type(s): Device
Intervention description(s): 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.
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.