NCT03142438

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database

Detailed description

Visit 1 will involve the participants being fitted with the F\&P trial full face or nasal mask for use in-home. The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one. 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 three weeks of the beginning of the study.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	F&P Seal Improvement Project	Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.

Timeline

• Start date: 2017-05-30
• Primary completion: 2017-06-23
• Completion: 2017-06-23
• First posted: 2017-05-05
• Last updated: 2021-07-14
• Results posted: 2021-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study