NCT02894242

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (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 as well as the patients overall acceptance of the mask.

Detailed description

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Conditions

• Sleep Disordered Breathing
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	F&P Deimos Nasal Pillows Mask	Investigative Nasal Pillows Mask to be used for OSA therapy

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2016-09-09
• Last updated: 2017-04-04

Locations

2 sites across 1 country: New Zealand