Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
310
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, United States
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Pullmonary Rehabilition Associates
Youngstown, Ohio, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Reading, Pennsylvania, United States
Proportion of participants requiring one or more mask re-fits
Proportion of participants in each arm requiring one or more mask re-fits.
Time frame: 90 days
Number of masks tried during the initial fitting visit
Number of masks tried during the initial fitting visit in each arm.
Time frame: 90 days
Number of masks tried after going home with the first mask
Number of masks tried after going home with the first mask in each arm.
Time frame: 90 days
Amount of time to fit each mask
Amount of time to fit each mask in each arm.
Time frame: 90 days
Number of sleep clinic or sleep center callbacks related to mask fitting issues
Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.
Time frame: 90 days
The amount of time spent on these calls to resolve mask issues
The amount of time spent on these calls to resolve mask issues in each arm.
Time frame: 90 days
Number of unplanned visits to adjust current mask or fit with another masks
Number of unplanned visits to adjust current mask or fit with another masks in each arm.
Time frame: 90 days
Duration of the unplanned visits
Duration of the unplanned visits in each arm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Time frame: 90 days
Adherence to CPAP therapy
Adherence to CPAP therapy as determined by average hours of use
Time frame: 90 days
Mask leak for chosen masks
Mask leak for chosen masks in each arm.
Time frame: 90 days
Subjective preference rated by patients
Patients will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.
Time frame: 90 days
Subjective preference rated by clinicians
Clinicians will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.
Time frame: 90 days