Obstructive Sleep Apnea Clinical Trial
Official title:
3-D Printer Custom Modified Continuous Positive Airway Pressure Masks to Improve Efficacy and Patient Compliance in Obstructive Sleep Apnea Management
This is a prospective pilot to investigate the effect of 3D printer customized CPAP masks on the comfort of patients with obstructive sleep apnea.
Purpose:
The purpose of this protocol is to perform a prospective pilot clinical study to customize
patient CPAP masks to reduce air leak in patients with obstructive sleep apnea (OSA). Using
3-D printer-based technology modeling of patient facial features, patient FDA-approved CPAP
masks will be modified by strategically applying silicone pads on the CPAP mask to mold to
the specific facial features to optimize the CPAP mask-patient interface, improve CPAP mask
fit and comfort, reduce air leak, limit air pressure loss and improve compliance with CPAP
treatment strategy (as measured over a 30 day trial period).
Protocol:
Potential subjects for this study will be identified at the outpatient Sleep Disorders Clinic
at BIDMC. Patients will have documented OSA, prescribed CPAP as standard-of-care, and
demonstrate consistent problems with CPAP mask-patient interface with documented high air
loss, and poor adherence/ compliance. All potential subjects will have used and will continue
to use an FDA-approved CPAP mask selected by the patient.
Potential subjects (along with their FDA-approved CPAP mask) will then be referred to the
BIDMC Specialties Clinic and screened, including review of the medical history of OSA, review
of documented reports of excessive air leak and suboptimal adherence to CPAP, brief physical
exam (esp. focusing on the head-and-neck exam) including assessment of the CPAP mask-patient
interface, review of the purpose and goals of the pilot clinical study, a dynamic video of
the study subject face will be performed, video downloaded to a computer which will then be
used to generate a 3-dimensional plastic model of the study subject face using
state-of-the-art 3D printer technology (see details below). The patient's FDA-approved CPAP
mask will then be applied to his plastic model of the study subject face, and the CPAP mask
modified with the application of silicon pads along the mask pillow cushion to optimize the
CPAP mask-face model interface, primarily by adjustments to improve CPAP mask contact with
the face model and limit the air leak during CPAP ventilation.
Once the patient's FDA-approved CPAP mask has been modified, the patient will then return to
the BIDMC Specialties Clinic for a final fitting of the modified CPAP mask, with additional
adjustments (as necessary) made to optimize the CPAP mask-patient interface. The study
subject will then return home with his/her custom-modified CPAP mask to use as prescribed.
Standard home monitoring and recording of use of the modified CPAP mask will be performed per
usual case over a 30-day period. Data obtained during this 30-day period will focus on the
duration of use of the modified CPAP mask, measurement of air leak and pressure loss, report
of patient comfort and experience with the modified CPAP mask, and compare to data over a 30
day period using the CPAP mask prior to modification.
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