NCT04615832

F&P Toffee Full Face Mask Clinical Trial, NZ, 2020

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy by a physician. This clinical trial will take place across three investigation sites with a sample of 45 participants.

Detailed description

The purpose of this clinical investigation was to evaluate the performance, comfort and ease of use of the F\&P Toffee Full Face Mask. The clinical investigation took place across three sites in order to recruit the required number of participants. The clinical investigation tested the mask on 44 participants, who were currently using a full face mask for PAP therapy. This was a non-randomized non-blinded single intervention study. Informed consent was gathered from the 44 participants before demographic and baseline measurements were recorded. Participants were issued an appropriate fitting Toffee Full face mask for the two week at home trial. After two weeks the participants returned the masks. At this visit device data was downloaded and participant questionnaires were completed.

Conditions

• Positive Airway Pressure Therapy
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Toffee Full Face Mask	Full face mask for PAP therapy applied in a home environment

Timeline

• Start date: 2020-11-10
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-11-04
• Last updated: 2021-12-01
• Results posted: 2021-11-05

Locations

3 sites across 1 country: New Zealand