Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to develop
      monitoring sensors that could be inserted into commercially available oral appliances in
      order to monitor effectiveness of the oral appliances in treating sleep apnea.
    

Detailed description: 
      Oral appliances are an accepted means to treat obstructive sleep apnea. In order to determine
      if they are effective, a polysomnogram needs to be conducted with the oral appliance in
      place. We propose to develop monitoring sensors that could be inserted into commercially
      available oral appliances in order to monitor effectiveness of the oral appliances in
      treating sleep apnea. We propose to look at heart rate variability as a marker for ongoing
      sleep apnea. We will use temperature as means of detecting how long the device is in the
      mouth as a means of assessing adherence.

      The objective of the Phase I project is to validate this hypothesis by answering five
      questions:

        -  What is the optimal sensor suite? We will determine the optimal suite of sensors that
           provides adequate sensitivity and specificity to determine OA usage and effectiveness
           without compromising patient comfort.

        -  Can we develop designs that are compatible with the most popular OAs? We will design and
           develop prototype versions of the OAMS that are compatible with three of the most
           popular commercially available OAMS products (potential candidates include EMA, TAP,
           SomnoDent, Herbst, Suad).

        -  Do experienced dental care providers who specialize in OAs approve of the designs? We
           will collaborate with dental care clinicians to iteratively refine the OAMS design for
           maximum performance and patient comfort.

        -  Does the OAMS provide data that are consistent with PSG instrumentation? We will
           collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders
           Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by
           comparing OSA-related OAMS data with data from standard PSG instrumentation.

        -  Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a
           detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and
           functional OAMS in a broad range of OSA patients who are candidates for an OA.
    

Intervention name(s): A novel monitoring suite of sensors will be inserted into the standard oral device.
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults diagnosed with obstructive sleep apnea who are currently being treated with an oral
        appliance or who wish to transition to an oral appliance
      
Keywords: Oral Appliance