Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022

NCT ID: NCT05573763

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-06-16

Brief Summary

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Toffee nasal pillows mask in a home environment.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm, non-randomized, and open-label

Group Type: OTHER

F&P Toffee

Intervention Type: DEVICE

Nasal pillows mask

Interventions

F&P Toffee

Nasal pillows mask

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Persons who are ≥22 years of age
• Persons who weigh ≥66 pounds
• Persons who have been prescribed PAP therapy by a physician
• Persons who are existing nasal pillows mask users with at ≥3 months of use prior to enrolment in the clinical trial
• Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
• Persons who are fluent in spoken and written English
• Persons who possess the capacity to provide informed consent

Exclusion Criteria

• Persons who are intolerant to PAP therapy
• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps
• Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
• Persons who have an IPAP pressure of >25 cmH2O if on BPAP
• Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2
• Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ohio Sleep Medicine Institute

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CIA-308

Identifier Type: -

Identifier Source: org_study_id