NCT02297789

Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Investigative Full Face Mask with Headgear

Timeline

• Start date: 2014-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-11-21
• Last updated: 2015-07-24

Locations

1 site across 1 country: New Zealand