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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06079866

Run by

ResMed

People needed

58

Starts

2023-10-04

Expected to finish

2023-11-20

Last updated by the study team

2024-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants willing to give written informed consent
• Participants who can read and comprehend English
• Participants who ≥ 18 years of age
• Participants being treated for OSA for ≥ 12 months
• Participants who have met CMS compliance for CPAP therapy over the last 3 months
• Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
• Participants currently using a suitable mask system*
• Participants who can trial the masks for up to 7 nights each
• Note*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)

You may not qualify if…

• Participants using Bi-level flow generators
• Participants who are or may be pregnant
• Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
• Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
• Participants who use a rental unit for AirSense 10 or AirSense 11 device
• Participants believed to be unsuitable for inclusion by the researcher

Where it is running

• Sleep Data — San Diego, California, United States
• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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