Oran Park Mask External Clinical Study (3) Marketing Claims Study

Status Completed

Clinical Trial Summary

The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Comparisons will be made against Fisher & Paykel's Evora Full mask system (referred to as Mask B in this study protocol, an FDA cleared benchmark mask) and the participant's own mask. Patients diagnosed with Obstructive Sleep Apnea and are current CPAP users on a tube down full-face mask system will be recruited to the study to evaluate the Oran Park mask system and the Evora Full mask system for up to 7 nights each, in the home environment, whilst using their own CPAP device. The overall purpose is to evaluate the performance of the prototype Oran Park mask system compared to an FDA cleared benchmark mask (Evora Full) in relation to seal, comfort, usability, ease of use, preference, AHI, and objective therapy data.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06079866
Study type	Interventional
Source	ResMed
Contact
Status	Completed
Phase	N/A
Start date	October 4, 2023
Completion date	November 20, 2023

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