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The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea

Clinical Trial Summary

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

Clinical Trial Description

Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F&P Toffee 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 Toffee 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 2 weeks of the beginning of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03726346
Study type Interventional
Source Fisher and Paykel Healthcare
Contact
Status Completed
Phase N/A
Start date November 26, 2018
Completion date November 13, 2019
View Details
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