NCT06079866

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

Assessment of the Seal, Comfort, Usability, and Performance of the Oran Park Mask System in the Home Environment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Mask A (Oran Park Mask) then Mask B (Evora Mask)	Mask A (Oran Park Mask) for 7 days followed by Mask B (Evora Mask) for 7 days
DEVICE	Mask B (Evora Mask) then Mask A (Oran Park Mask)	Mask B (Evora Mask) for 7 days followed by Mask A (Oran Park Mask) for 7 days.

Timeline

• Start date: 2023-10-04
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2023-10-12
• Last updated: 2024-02-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study