NCT03413098

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (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 mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed description

Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F\&P trial nasal mask for use in-home. The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two. 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 patients within 1 week of the beginning of the study.

Conditions

• Obstructive Sleep Apnea

Interventions

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

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2018-01-29
• Last updated: 2018-03-22

Locations

2 sites across 1 country: New Zealand