Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02741635
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Sponsor:
Fisher and Paykel Healthcare
Organization:
Study Overview
Official Title:
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Status:
COMPLETED
Status Verified Date:
2024-08
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 performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.
A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.
The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.
The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: