Trial Outcomes & Findings for Evaluation of the F&P Caramel Nasal Mask, US, 2023 (NCT NCT06060717)

NCT ID: NCT06060717

Last Updated: 2025-09-23

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 AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline and14±5 days
• Results posted on: 2025-09-23

Participant Flow

Participant milestones

Measure	Caramel Nasal Mask Participants to use nasal mask for 14 days. Caramel Nasal Mask:Nasl mask for the treatment of obstructive sleep apnea (OSA)
Overall Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the F&P Caramel Nasal Mask, US, 2023

Baseline characteristics by cohort

Measure	F&P Caramel: Nasal Mask n=43 Participants Participants to use nasal mask for 14 days. Caramel Nasal Mask: Nasal mask for the treatment of obstructive sleep apnea (OSA).
Age, Customized	43 Participants n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	25 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and14±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 AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device.

Higher AHI values represent worse outcomes. There is no maximum theoretical index score.

Outcome measures

Measure	F&P Caramel: Nasal Mask n=43 Participants Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use.
Therapeutic Efficacy	1.69 events per hour Interval 0.2 to 17.3

PRIMARY outcome

Timeframe: Baseline and14±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

Measure	F&P Caramel: Nasal Mask n=43 Participants Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use.
Epworth Sleepiness Scale	7 Epworth Sleepiness Score (ESS) Interval 0.0 to 13.0

Adverse Events

F&P Caramel: Nasal Mask

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	F&P Caramel: Nasal Mask n=43 participants at risk Participants to use nasal mask for 14 days. Caramel Nasal Mask: Nasal mask for the treatment of obstructive sleep apnea (OSA).
Respiratory, thoracic and mediastinal disorders Common Cold	9.3% 4/43 • Number of events 4 • 14 days

Additional Information

Kelly Tay

Fisher & Paykel Healthcare Ltd

Phone: +64 9-282-9734

Email: kelly.tay@fphcare.co.nz

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place