NCT03272763

A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Detailed description

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two. The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	F&P Toffee mask	Trial Full-Face mask which comes with three seal sizes and two headgear sizes.

Timeline

• Start date: 2017-10-09
• Primary completion: 2017-10-29
• Completion: 2018-10-09
• First posted: 2017-09-06
• Last updated: 2022-06-21
• Results posted: 2022-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study