Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06079866
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2023-10-06
Brief Title:
Oran Park Mask External Clinical Study 3 Marketing Claims Study
Sponsor:
ResMed
Organization:
ResMed
Study Overview
Official Title:
Assessment of the Seal Comfort Usability and Performance of the Oran Park Mask System in the Home Environment
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Paykels Evora Full mask system referred to as Mask B in this study protocol an FDA cleared benchmark mask and the participants 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D646-159 | OTHER | ResMed | None |