Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
Evaluation of An Optical Measurement Algorithm Combined With Patient and Provider Input to Reduce Mask Exchanges During Initial Positive Airway Pressure Therapy
Continuous positive airway pressure and non-invasive ventilation are common treatment
 modalities for obstructive sleep apnea, central sleep apnea, and chronic alveolar
 hypoventilation from a variety of causes. Use of positive airway pressure (PAP) requires use
 of an interface, commonly referred to as a "mask." There are a range of mask options
 available, differing in configuration and sizing, including masks that fit into the nostrils
 (nasal pillows, NP), cover the nose (nasal masks, NM), cover both the nose and the mouth
 (oronasal masks, ONM), and rarely those that fit into the mouth (oral masks, OM) or over the
 entire face. The variety of masks, sizes, and materials result from the wide variety of
 facial configurations and patient preferences along with requirements to provide a good seal
 for varying pressure requirements. Failure to find a good match for a given patient may
 result in significant side effects, such as eye irritation owing to leak into the eyes, skin
 pressure sores, noise generation, and inadequate therapy when air leaks are extreme. Pressure
 sores, mask dislodgement, claustrophobic complaints, air leaks, and sore eyes occur in 20-50%
 of patients with OSA receiving PAP, and these effects negatively correlate with PAP
 compliance. Furthermore, several trials point to differences in compliance related to which
 types of masks are utilized. In a randomized cross-over trial, compliance was 1 hour more per
 night in patients using NM compared to those using ONM.1 In another, NPs were associated with
 fewer adverse effects and better subjective sleep quality than NMs.2 Therefore, failure to
 find an acceptable mask results in lower or non-compliance, and therefore treatment failure.

 Currently, finding a right mask is performed either using crude templates, or via an
 iterative process, variably guided by experts in mask fitting. There are no standard
 certifications or algorithms to guide mask fitting. Given the above, it would be very
 desirable to find a reliable method to reduce the errors in mask fitting so that the costs,
 inconvenience, and suffering are all reduced.
Patients will be recruited from Mayo Clinic sleep medicine practices who have completed
 testing and are initiating PAP therapy for obstructive sleep apnea (OSA), obesity
 hypoventilation syndrome (OHS), or central sleep apnea syndrome (CSA). Testing will be
 performed for clinical reasons on patients referred for evaluation for sleep disordered
 breathing. Testing is at the clinician's discretion and can be either polysomnography or home
 sleep apnea tests. Patients meeting inclusion and not meeting exclusion criteria will be
 offered the opportunity to participate in this study.
Inclusion Criteria:

 -  Age ≥18 years old

 -  Sleep testing shows an apnea-hypopnea index or respiratory event index ≥5

 -  Patient is PAP naïve.

 -  Patient's diagnosis is obstructive sleep apnea, obesity hypoventilation syndrome, or
 central sleep apnea syndrome

 -  Prescribed therapy is CPAP, A-PAP, or BPAP in a spontaneous modality

 -  Patient is able to provide consent

 -  Patient is English speaking (limited to English for device)

 Exclusion Criteria:

 -  Prescribed therapy is BPAP ST or ASV

 -  Patient is not able to provide consent

 -  Patient is not able to speak or read English

 -  Nasal or facial trauma or surgery that leaves atypical facial features

 Protocol:

 Eligible patients will be randomized to Active or Usual Care using randomizer.com. This is
 the differentiating part of the study, with the prescription for a mask being decided by
 these two different processes:

 -  Patients in the Active group will provide their inputs and have measurements obtained
 using MyMask™. The initial mask choice will be influenced by this interaction. If the
 patient is disinclined to accept the first recommendation offered by this application,
 the second, third, and so on will be offered to the patient. The initial prescription
 will then be issued for that particular mask.

 -  Patients in the Usual Care group will engage in initial mask choice by viewing
 different options of mask styles using a standard online poster that demonstrates NM,
 NP, ONM, and Combination masks, and then choosing which type they would like ordered.

 An initial follow-up visit will be scheduled to occur either face to face or via video
 visit between day 31-90 of PAP use. This is a standard clinical visit, and the patient will
 be asked about their experience, the effects of therapy, and a download of their PAP
 machine will be obtained. Standard information will be gathered at this visit:

 Standard 31-90 day visit data:

 -  Epworth Sleepiness Scale

 -  PROMIS 10

 -  PAP satisfaction questionnaire (CPAP Questionnaire is a 12 item questionnaire, with
 items 1-6 a Likert like scale asking about various types of discomfort, and questions
 7-12 using a 100 mm VAS to answer questions related to PAP and sleep satisfaction).

 In addition, a video or telephone visit will be as soon after 90 days as possible to
 collect:

 -  PAP compliance and leak rate data

 -  PAP satisfaction questionnaire data

 -  History of how many different masks were used since initial prescription o Which type
 of mask the patient was using at Day 90