NCT05496062

Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Detailed description

This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F\&P Toffee Nasal or Toffee Nasal Pillows mask. The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	F&P Toffee Nasal and Toffee Nasal Pillows Masks	F\&P Toffee Nasal and Toffee Nasal Pillows Masks are intended to be used within the traditional PAP therapy system and are designed to facilitate equivalent PAP therapeutic efficacy as defined by standard practice.

Timeline

• Start date: 2022-09-12
• Primary completion: 2022-10-07
• Completion: 2024-04-30
• First posted: 2022-08-10
• Last updated: 2024-05-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study