Trial Outcomes & Findings for Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022 (NCT NCT05573763)

Results Overview

Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Baseline and 14±5 days

Results posted on

2025-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Toffee: Nasal Pillows Mask Participants to use nasal pillows mask for 14 days. Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	F&P Toffee: Nasal Pillows Mask n=39 Participants Participants to use nasal pillows mask for 14 days. Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Age, Customized 22+ years of age	39 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14±5 days

Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe"

Outcome measures

Outcome measures
Measure	F&P Toffee: Nasal Pillows Mask n=39 Participants Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy. 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.
Therapeutic Efficacy	2 events per hour Interval 0.3 to 4.5

PRIMARY outcome

Timeframe: 14±5 days

All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes)

Outcome measures

Outcome measures
Measure	F&P Toffee: Nasal Pillows Mask n=39 Participants Participants will be placed in the experimental arm for 14 days, during which they will be using either the Toffee Nasal or Toffee Nasal Pillows mask for PAP therapy. 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.
Epworth Sleepiness Scale	10 Scores on a scale Interval 0.0 to 13.0

Adverse Events

F&P Toffee: Nasal Pillows Mask

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	F&P Toffee: Nasal Pillows Mask n=39 participants at risk Participants to use nasal pillows mask for 14 days. Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
General disorders Sinus Cold	2.6% 1/39 • Number of events 1 • 14 days 0
Musculoskeletal and connective tissue disorders Muscle soreness	2.6% 1/39 • Number of events 1 • 14 days 0

Additional Information

Kelly Tay

Fisher & Paykel Healthcare Ltd

Phone: +64 9-282-9734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place