NCT03605485

The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Detailed description

Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F\&P trial nasal pillows mask for use in-lab. The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night. The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Nasal Pillows CPAP mask	Investigative Nasal pillows Mask to be used for OSA therapy

Timeline

• Start date: 2018-08-07
• Primary completion: 2018-08-10
• Completion: 2018-08-10
• First posted: 2018-07-30
• Last updated: 2018-08-15

Locations

1 site across 1 country: New Zealand