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The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Clinical Trial Summary

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Clinical Trial Description

This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days. The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days. Visit Three will involve the participants returning the second trial seal and providing feedback. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03230877
Study type Interventional
Source Fisher and Paykel Healthcare
Contact
Status Completed
Phase
Start date September 2, 2017
Completion date November 30, 2017
View Details
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