Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT02323035
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2014-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigative Headgear With CPAP Mask
Sponsor:
Fisher and Paykel Healthcare
Organization:
Study Overview
Official Title:
Investigative Headgear With CPAP Mask
Status:
COMPLETED
Status Verified Date:
2019-04
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:
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.
Detailed Description:
Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: