NCT02741635

The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	New Nasal Pillows Mask	Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-04-18
• Last updated: 2024-09-19
• Results posted: 2020-05-15

Locations

1 site across 1 country: New Zealand