NCT03230877

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

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

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

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Toffee full face mask with 'Improved Seal'	Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
DEVICE	Toffee full face mask with 'Normal Seal'	Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.

Timeline

• Start date: 2017-09-02
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2017-07-27
• Last updated: 2022-09-08
• Results posted: 2022-09-08

Locations

1 site across 1 country: United States