Validation of a Simplified MATRx Plus
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat
      passage and allowing normal breathing.

      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has
      invented a feedback-controlled device that tests various positions of the lower jaw. This
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA
      cleared motorized dental positioner that can be used in an overnight sleep study performed in
      the home. Temporary dental impression trays cover your upper and lower teeth. These are
      attached to a small motor that slowly and gently pulls your lower jaw forward under the
      control of a computer in response to real-time breathing events. The commercial MATRx plus
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a
      simplified version of the test that requires fewer sensors and sleep time.
    

Detailed description: 
      Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly
      closes during sleep and repeatedly interrupts breathing. The standard treatment for sleep
      apnea is continuous positive airway pressure (CPAP), but it is not suitable for all patients.
      Another treatment is to use an oral appliance in your mouth when you sleep. The appliance
      covers the upper and lower teeth and acts to pull the lower jaw forward, opening the throat
      passage and allowing normal breathing.

      Oral appliance therapy does not treat sleep apnea effectively in everyone. In order to
      identify the people in whom oral appliance therapy will work, Zephyr Sleep Technologies has
      invented a feedback-controlled device that tests various positions of the lower jaw. This
      commercially available device, known as MATRx plus, is a Health Canada approved and FDA
      cleared motorized dental positioner that can be used in an overnight sleep study performed in
      the home. Temporary dental impression trays cover your upper and lower teeth. These are
      attached to a small motor that slowly and gently pulls your lower jaw forward under the
      control of a computer in response to real-time breathing events. The commercial MATRx plus
      device uses measures of airflow from a nasal cannula and blood oxygen saturation from a pulse
      oximeter to guide the movement of the lower jaw during the test. Though the test is accurate,
      the equipment can be somewhat cumbersome to apply. The purpose of the study is to validate a
      simplified version of the test that requires fewer sensors and sleep time.

      We have previously carried out three research studies leading to the development of the
      feedback-controlled mandibular positioner. These studies, two of which used early prototypes
      of the device and one that used the commercial MATRx plus device, showed that the
      feedback-control software used was very accurate and was able to identify successful
      candidates in a home setting.

      No serious or permanent problems or risks were identified in any of the previous research
      studies. Participants reported minor tooth and gum discomfort on the morning following the
      test and other minor issues including dry mouth, excessive saliva, and being unable to sleep.
      The previous studies have established the safety and efficacy of the device using a device
      prototype. The purpose of the present study is to determine if the efficacy of the device is
      maintained when fewer sensors are used and the requirement for sleep time is reduced.

      The study will collect data over one night in a sleep laboratory and a series of nights in
      the home. Following the study, you will be told if you are a suitable candidate for oral
      appliance therapy. If you do not already have a custom oral appliance, one will be provided
      to you. During the study, the Principal Investigator and study dentist will be blinded to the
      results of your tests. In the event of an emergency, the Principal Investigator can be
      unblinded to your test results.

      Up to 46 individuals will be recruited for this study. Study participants will need to attend
      visits at multiple centres located in Calgary, Alberta.
    

Intervention name(s): MATRx plus
Intervention type(s): Device
Intervention description(s): The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will be representative of the general population of individuals with
        obstructive sleep apnea in North America.
      
Keywords: Oral appliance therapy